Gas chromatography-mass spectrometry detection method for sildenafil in health care product

Abstract

The invention discloses a gas chromatography-mass spectrometry detection method for sildenafil in a health care product, and relates to the technical field of medicine detection.The gas chromatography-mass spectrometry detection method comprises the following steps that a health care product sample is fully ground into fine particles, and sample powder is obtained; transferring the sample powder into a clean extraction container, adding an extraction solvent into the extraction container, sealing the extraction container, placing the extraction container on an oscillator for oscillation, centrifuging after oscillation is finished, and extracting the sildenafil component in the sample powder into supernate; transferring the supernate into a clean chromatographic sample injection bottle, carrying out gas chromatography-mass spectrometry detection analysis, and recording a chromatogram and a mass spectrum; qualitatively analyzing the sample; according to the gas chromatography-mass spectrometry detection method for sildenafil in the health care product, no matter which form a detected sample is in, the detection condition can be met, the chromatographic peak shape of sildenafil in detection is good, the detected sample is simple and convenient to treat, the reproducibility is good, and the method is suitable for qualitative analysis of sildenafil in various detection materials of solid samples.

Description

Technical Field

[0001] The invention relates to a drug detection technology, and in particular to a gas chromatography-mass spectrometry detection method for sildenafil in health products. Background Art

[0002] Sildenafil, also known as Viagra, is a white crystalline powder with a molecular formula of C 22 H 30 N6O4S, molecular weight 474.58, boiling point 672℃, CAS number: 139755-83-2, is a drug for treating male erectile dysfunction that was accidentally invented during the development of drugs for treating cardiovascular diseases. Overdose can cause cardiovascular and cerebrovascular problems and it is a strictly controlled prescription drug.

[0003] At present, the main methods for testing sildenafil in the existing technology are spectrophotometry, thin layer chromatography, and high performance liquid chromatography-mass spectrometry. In cases involving food, medicine, and environmental protection, the test materials are diverse in form, and sildenafil may exist in many different types of matrices, such as food additives, pharmaceutical preparations, water bodies, soil, etc. The chemical composition of these matrices themselves is complex, which can easily produce significant matrix effects on the detection of sildenafil; and sildenafil has a large molecular weight, a high boiling point, is difficult to vaporize, and has a late peak, which can easily cause missed detection, thereby affecting the accuracy of the test results. Summary of the invention

[0004] The purpose of the present invention is to provide a gas chromatography-mass spectrometry detection method for sildenafil in health products to solve the above-mentioned shortcomings in the prior art.

[0005] In order to achieve the above object, the present invention provides the following technical solution: a gas chromatography-mass spectrometry detection method for sildenafil in health products, comprising the following steps:

[0006] S1. Sample preparation: Use a clean, uncontaminated mortar and pestle to fully grind the health product sample into fine particles to obtain sample powder;

[0007] S2. Extraction of sildenafil components: transfer the sample powder to a clean extraction container, add the extraction solvent to the extraction container, seal the extraction container and place it on an oscillator for oscillation, centrifuge after the oscillation, and extract the sildenafil components in the sample powder into the supernatant;

[0008] S3. Gas chromatography-mass spectrometry: The supernatant was transferred to a clean chromatographic injection bottle for gas chromatography-mass spectrometry analysis. The detection procedure was as follows: the initial temperature was maintained at 100°C for 1 min, and then the temperature was increased to 300°C at a rate of 20°C / min for 50 min. The injection port temperature was 230°C, and the chromatogram and mass spectrum were recorded.

[0009] S4. Qualitative analysis of samples: If the sample elution time is consistent with the retention time of the sildenafil standard substance, and the mass spectrum characteristic peak and its abundance ratio are consistent with the sildenafil standard substance, then the sildenafil component is detected in the sample; if the sildenafil characteristic ion peak is detected in the 0.002 mg / mL sildenafil standard solution by gas chromatography-mass spectrometry, and the sildenafil characteristic ion peak is not detected in the sample with a concentration of 10 mg / mL, then the sildenafil component is not detected in the sample.

[0010] Furthermore, the detection limit of the detection method is 0.5 μg / mL.

[0011] Furthermore, the health care product sample described in S1 is a solid preparation.

[0012] Furthermore, the mass of the sample powder transferred to the clean extraction container in S2 is 10 mg.

[0013] Furthermore, the extraction solvent in S2 is a mixed solution of chloroform and methanol in a volume ratio of 9:1.

[0014] Furthermore, the volume of the extraction solvent added to the extraction container in S2 is 10 mL.

[0015] Furthermore, the oscillation time of the oscillation in S2 is 10-15 minutes.

[0016] Furthermore, the chromatographic column type of the chromatography described in S3 is a HP-5MS chromatographic column.

[0017] Furthermore, the chromatographic column parameters of the chromatography described in S3 are 30m×0.25mm×0.25μm.

[0018] Furthermore, during the gas chromatography-mass spectrometry detection process described in S3, a 0.002 mg / mL sildenafil standard solution is simultaneously analyzed for quality control.

[0019] Compared with the prior art, the gas chromatography-mass spectrometry detection method for sildenafil in health products provided by the present invention can meet the inspection conditions regardless of the form of the detection sample, and the chromatographic peak shape of sildenafil in the detection is good, the detection sample processing is simple, and the reproducibility is good. It is suitable for the qualitative analysis of sildenafil in various types of solid sample materials and has guiding significance for the inspection of sildenafil. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0021] Figure 1 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample at an initial temperature of 70°C and a final temperature of 250°C;

[0022] Figure 2 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample with an initial temperature of 100°C and a final temperature of 250°C;

[0023] Figure 3 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample at an initial temperature of 150°C and a final temperature of 250°C;

[0024] Figure 4 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample at an initial temperature of 200°C and a final temperature of 250°C;

[0025] Figure 5 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample with an initial temperature of 70°C and a final temperature of 280°C;

[0026] Figure 6 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample with an initial temperature of 100°C and a final temperature of 280°C;

[0027] Figure 7 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample at an initial temperature of 150°C and a final temperature of 280°C;

[0028] Figure 8 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample with an initial temperature of 200°C and a final temperature of 280°C;

[0029] Fig. 9 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample at an initial temperature of 70°C and a final temperature of 300°C;

[0030] Fig.10 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample at an initial temperature of 100°C and a final temperature of 300°C;

[0031] Fig.11 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample at an initial temperature of 150°C and a final temperature of 300°C;

[0032] Fig.12 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample at an initial temperature of 200°C and a final temperature of 300°C;

[0033] Fig.13The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample with an initial temperature of 70°C and a final temperature of 320°C;

[0034] Fig.14 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample with an initial temperature of 100°C and a final temperature of 320°C;

[0035] Fig.15 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample at an initial temperature of 150°C and a final temperature of 320°C;

[0036] Fig.16 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample with an initial temperature of 200°C and a final temperature of 320°C;

[0037] Fig.17 The total ion current diagram of the sildenafil standard sample with a retention time of 20 min provided in an embodiment of the present invention;

[0038] Fig.18 The total ion current diagram of the sildenafil standard sample with a retention time of 30 min provided in an embodiment of the present invention;

[0039] Fig.19 The total ion current diagram of the sildenafil standard sample with a retention time of 50 min provided in an embodiment of the present invention;

[0040] Fig. 20 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample with a heating rate of 20°C / min;

[0041] Fig.21 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample with a heating rate of 50°C / min;

[0042] Fig. 22 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample at a heating rate of 100°C / min;

[0043] Fig.23 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample at an injection port temperature of 200°C / min;

[0044] Fig.24 The total ion current diagram of the sildenafil standard sample with an injection port temperature of 230°C / min provided in an embodiment of the present invention;

[0045] Fig.25 The total ion current diagram of the sildenafil standard sample with an injection port temperature of 250°C / min provided in an embodiment of the present invention;

[0046] Fig.26 The total ion current diagram of the sildenafil standard sample with an injection port temperature of 280°C / min provided in an embodiment of the present invention;

[0047] Fig. 27 The detection procedure provided for the embodiment of the present invention is the total ion current diagram of the sildenafil standard sample;

[0048] Fig.28 The total ion current diagram of the sildenafil standard sample after ten days provided in the embodiment of the present invention;

[0049] Fig.29 This is the total ion current diagram of the sildenafil standard sample after ten hours provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0050] In order to enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings.

[0051] Embodiment 1:

[0052] A gas chromatography-mass spectrometry detection method for sildenafil in health products comprises the following steps:

[0053] S1. Sample preparation: Use a clean, uncontaminated mortar and pestle to fully grind the solid preparation health product sample into fine particles to obtain sample powder;

[0054] S2. Extraction of sildenafil components: 10 mg of sample powder was transferred to a clean extraction container. After adding 10 mL of extraction solvent to the extraction container, the extraction container was sealed and placed on an oscillator for 10-15 min. After the oscillation, the container was centrifuged to extract the sildenafil components in the sample powder into the supernatant. The extraction solvent was a mixed solution of chloroform and methanol in a volume ratio of 9:1.

[0055] S3. Gas chromatography-mass spectrometry detection: The supernatant and the sildenafil standard solution with a concentration of 0.002 mg / mL were transferred to clean chromatographic injection bottles, respectively, and analyzed by gas chromatography-mass spectrometry, and the chromatogram and mass spectrum were recorded. The chromatographic column type was HP-5MS chromatographic column, and the chromatographic column parameters were 30 m×0.25 mm×0.25 μm;

[0056] S4. Qualitative analysis of samples: If the elution time of the sample is consistent with the retention time of the sildenafil standard substance, and the mass spectrum characteristic peak and its abundance ratio are consistent with the sildenafil standard substance, then the sildenafil component is detected in the sample; if the sildenafil characteristic ion peak is detected in the gas chromatography-mass spectrometry analysis of 0.002 mg / mL sildenafil standard solution, and the sildenafil characteristic ion peak is not detected in the sample with a concentration of 10 mg / mL, then the sildenafil component is not detected in the sample; the detection limit of this detection method is 0.5 μg / mL.

[0057] The specific implementation method is as follows:

[0058] S1. Sample preparation:

[0059] S11. Equipment preparation: Make sure the mortar and pestle have been thoroughly cleaned and dried without any chemical residue or contaminants.

[0060] S12. Sample weighing: Use an electronic balance accurate to 0.1 mg to weigh 10 mg of solid dosage health product sample.

[0061] S13. Grinding operation: Pour the weighed health product sample carefully into the mortar, grind it gently with a pestle to avoid splashing the sample, and continue grinding until the sample becomes a uniform, fine granular powder. Check whether there are large pieces of unground sample in the powder, and continue grinding until it is completely refined to obtain the sample powder.

[0062] S14. Powder collection: Transfer the ground sample powder to a clean, dry container and cover it with a lid to prevent contamination.

[0063] S2. Extraction of Sildenafil ingredients:

[0064] S21. Preparation of extraction solvent: Measure 90 mL of chloroform and 10 mL of methanol, mix them evenly to obtain an extraction solvent, and mix them thoroughly before use.

[0065] S22. Sample transfer: Accurately transfer 10 mg of sample powder into a clean extraction container.

[0066] S23. Solvent addition: slowly add 10 mL of the prepared extraction solvent into the extraction container to avoid splashing.

[0067] S24, oscillation extraction: After the extraction container is sealed, it is placed on an oscillator, and the oscillation frequency and time (150 rpm, 10-15 minutes) are set. During the oscillation process, observe whether the container is well sealed to prevent solvent volatilization.

[0068] S25. Centrifugal separation: After the shaking is completed, the extraction container is placed in a centrifuge and centrifuged at 3000 rpm for 5-10 minutes to precipitate the solid particles and dissolve the sildenafil component in the supernatant.

[0069] S26. Supernatant collection: Carefully transfer the supernatant to a clean chromatographic injection bottle to avoid contact with the precipitate.

[0070] S3, Gas chromatography-mass spectrometry detection

[0071] S31. Instrument preparation: Ensure that the gas chromatograph-mass spectrometer (GC-MS) is in good working condition, and set the appropriate chromatographic column type (HP-5MS) and parameters (30m×0.25mm×0.25μm).

[0072] S32. Preparation of standard solution: Prepare a sildenafil standard solution with a concentration of 0.002 mg / mL and transfer it to a clean chromatographic injection bottle.

[0073] S33, injection analysis: inject the supernatant and standard solution into GC-MS for analysis, record the chromatogram and mass spectrum, and save the data for subsequent analysis.

[0074] S4. Qualitative analysis of samples

[0075] If the peak elution time of the sample is consistent with the retention time of the sildenafil standard substance, and the mass spectrometry characteristic peak and its abundance ratio are consistent with the sildenafil standard substance, the sildenafil component is detected in the sample; if the sildenafil characteristic ion peak is detected in the gas chromatography-mass spectrometry analysis of 0.002 mg / mL sildenafil standard solution, and the sildenafil characteristic ion peak is not detected in the sample with a concentration of 10 mg / mL, the sildenafil component is not detected in the sample; the detection limit of this detection method is 0.5 μg / mL.

[0076] Embodiment 2:

[0077] This embodiment provides a technical solution based on the first embodiment: the detection procedure of gas chromatography-mass spectrometry is optimized, and the optimal detection procedure is to maintain the initial temperature at 100°C for 1 min, increase the temperature to 300°C at a heating rate of 20°C / min for 50 min, and the injection port temperature is 230°C.

[0078] 1. Optimization of initial temperature and end temperature

[0079] The sildenafil standard substance solution was tested at 70°C, 100°C, 150°C, and 200°C as the starting temperature, 20°C / min as the heating rate, and the temperature was raised to 250°C, 280°C, 300°C, and 320°C respectively for 50 minutes, with the injection port temperature at 230°C. Please refer to the table below for the test results:

[0080]

[0081] See also Figure 1-Figure 16 According to the analysis of the experimental spectrum, the initial temperature has no substantial effect on the test results, but only affects the peak time. Considering the diversity of the test materials, the initial temperature is recommended to be 100℃; when the end temperature is 250℃, the test results are all undetectable; when the end temperature is 280℃, sildenafil is detected, and the peak time is after 50min; when the end temperature is 300℃, sildenafil is detected, and the peak time is about 35min; when the end temperature is 320℃, sildenafil is detected, and the peak time is about 20min. Therefore, 250℃ and 280℃ are not suitable as the end temperature. Sildenafil peaks earlier at 320℃ than at 300℃, but the maximum temperature that the chromatographic column can withstand is 350℃, which will greatly shorten the service life of the chromatographic column. Therefore, it is not recommended to set the end temperature to 320℃, and it is appropriate to set the end temperature to 300℃.

[0082] 2. Analysis time optimization

[0083] The temperature program was set to maintain at 100°C for 1 min and then increase to 300°C at 20°C / min. The duration was set as a variable and other conditions remained unchanged for testing.

[0084] In the testing process of sildenafil in solid dosage health products, duration is one of the key factors affecting the test results. Figure 17-Figure 19 The experimental data it displays can clearly show the detection status of sildenafil at different durations.

[0085] Specifically, when the final temperature duration of the column was set to 20 minutes, sildenafil was not successfully detected despite the carefully controlled experimental conditions. This result suggests that the shorter duration may not be sufficient to fully separate the sildenafil in the sample and reach a detectable level, resulting in missed detection.

[0086] Subsequently, when the duration was extended to 30 minutes, although sildenafil was successfully detected, its peak time was relatively delayed. This shows that although a longer time is helpful for the separation and detection of sildenafil, a too late peak time may also increase the uncertainty and complexity of the detection process, thereby increasing the risk of missed detection.

[0087] Finally, when the duration was set to 50 minutes, the experimental results showed the most ideal detection effect. Under this condition, sildenafil was not only successfully detected, but also its peak time was moderate, neither too early nor too late, ensuring the accuracy and reliability of the test results. Therefore, it can be considered that the duration of 50 minutes is a more appropriate choice for the final temperature control of the chromatographic column under the current experimental conditions. For specific detailed records, please refer to the table below:

[0088]

[0089] 3. Optimization of heating rate

[0090] The initial temperature was set at 100°C and maintained for 1 min. The temperature was then raised to 300°C and maintained for 50 min. The heating rate was set as a variable and other conditions remained unchanged for testing.

[0091] Despite the significant differences in heating rates, this variable did not have a substantial impact on the accuracy of the overall test results or the detection of sildenafil. In other words, both fast and slow heating rates were effective in detecting sildenafil in the samples.

[0092] However, the change in heating rate does have a significant effect on the peak elution time. A faster heating rate will result in an earlier peak elution time, while a slower heating rate will result in a later peak elution time. Since the components of the sample are often complex and diverse, the resolution of the chromatographic peaks becomes a critical consideration.

[0093] In view of the above analysis, it is recommended that the heating rate be set to 20℃ / min in similar detection tasks. This choice is not only conducive to the full separation of the chromatographic peaks of each component, improving the accuracy and reliability of the detection, but also to a certain extent avoids the peak distortion or overlap caused by too fast a heating, thereby ensuring the comprehensiveness and accuracy of the detection results. For specific detailed records, please refer to the table below:

[0094]

[0095] 4. Inlet temperature optimization

[0096] The temperature rising program was set to 100℃ (1min) 20℃ / min 300℃ (50min), and the injection port temperature was determined as a variable, and was set to 200℃, 230℃, 250℃, and 280℃ for injection and inspection.

[0097] See also Figure 23-Figure 26 ,When the injection port temperature was set to 200 °C, sildenafil was not successfully detected, which may indicate that at this temperature, sildenafil was not fully vaporized and entered the chromatographic column, resulting in missed detection.

[0098] However, as the injection port temperature increased, the detection of sildenafil improved. At injection port temperatures of 230°C, 250°C, and 280°C, sildenafil was successfully detected at 37.927 minutes, indicating that sildenafil could be effectively vaporized and captured by the chromatographic column under these temperature conditions; when the injection port temperature reached 280°C, in addition to the main peak of sildenafil, an interference peak appeared at 14.539 minutes, which may be due to the decomposition of certain components at high temperatures or the generation of new volatile substances.

[0099] In order to prevent the target sildenafil from decomposing at high temperatures or being interfered with by other components, the injection port temperature was set to 230°C, taking into account the detection efficiency and accuracy. This temperature can not only ensure the effective vaporization and detection of sildenafil, but also minimize the appearance of interference peaks, thereby providing more accurate and reliable detection results. For specific detailed records, please refer to the table below:

[0100]

[0101] 5. Inter-day precision and intra-day precision

[0102] The temperature rising program was set to 100℃(1min) 20℃ / min 300℃(50min), and the time was determined as a variable to test the intra-day and inter-day errors respectively.

[0103] See also Figure 27-Figure 29 , as shown in the figure, the sildenafil standard working solution was subjected to GC / MS analysis with an injection port temperature of 230°C and a temperature program set to 100°C (1min) 20°C / min 300°C (50min), and the sample was injected ten days later and ten hours later on the same day.

[0104] Whether it is the inter-day error (i.e., sampling and analysis again after ten days) or the intra-day error (i.e., sampling again after ten hours at different time periods within the same day), the peak time of sildenafil maintained a high degree of stability and consistency, and the error range was within an acceptable range.

[0105] This result shows that the detection method has good reproducibility and stability, and can provide accurate and reliable detection results at different time points. This is of great significance for ensuring the reliability and repeatability of experimental results and meeting the requirements of scientific research and legal testing.

[0106] In summary, the stability and reproducibility of the chromatographic analysis method were further verified by investigating the time variable, providing a more solid technical support for the detection of sildenafil in solid dosage health products. At the same time, this finding also provides a useful reference and reference for the optimization and application of similar chromatographic analysis methods.

[0107] 6. Minimum detection limit

[0108] The prepared sildenafil standard working solutions with concentrations of 2μg / mL, 1μg / mL, 0.5μg / mL, and 0.2μg / mL were subjected to GC / MS analysis at an injection port temperature of 230℃ and a temperature program of 100℃ (1min) 20℃ / min300℃ (50min). Sildenafil was detected in the 2μg / mL, 1μg / mL, and 0.5μg / mL sildenafil standard working solutions, and only the sildenafil M / Z99 characteristic ion peak was detected in the 0.2μg / mL sildenafil standard solution. Therefore, the detection limit of this method is 0.5μg / mL.

[0109] The above description is only by way of illustration of certain exemplary embodiments of the present invention. It is undoubted that those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the above drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. A gas chromatography-mass spectrometry detection method for sildenafil in health products, characterized in that: The steps include: S1. Sample preparation: Use a clean, uncontaminated mortar and pestle to fully grind the health product sample into fine particles to obtain sample powder; S2. Extraction of sildenafil components: transfer the sample powder to a clean extraction container, add the extraction solvent to the extraction container, seal the extraction container and place it on an oscillator for oscillation, centrifuge after the oscillation, and extract the sildenafil components in the sample powder into the supernatant; S3. Gas chromatography-mass spectrometry detection: transfer the supernatant to a clean chromatography injection bottle, perform gas chromatography-mass spectrometry detection and analysis, and record the chromatogram and mass spectrum; S4. Qualitative analysis of samples: If the sample elution time is consistent with the retention time of the sildenafil standard substance, and the mass spectrum characteristic peak and its abundance ratio are consistent with the sildenafil standard substance, then the sildenafil component is detected in the sample; if the sildenafil characteristic ion peak is detected in the 0.002 mg / mL sildenafil standard solution by gas chromatography-mass spectrometry, and the sildenafil characteristic ion peak is not detected in the sample with a concentration of 10 mg / mL, then the sildenafil component is not detected in the sample.

2. The gas chromatography-mass spectrometry detection method for sildenafil in a health product according to claim 1, characterized in that: The detection procedure of the gas chromatography-mass spectrometry analysis described in S3 is as follows: the initial temperature is maintained at 100°C for 1 min, the temperature is increased to 300°C at a heating rate of 20°C / min and the temperature is maintained for 50 min, and the injection port temperature is 230°C.

3. The gas chromatography-mass spectrometry detection method for sildenafil in a health product according to claim 1, characterized in that: The detection limit of the detection method is 0.5 μg / mL.

4. The gas chromatography-mass spectrometry detection method for sildenafil in a health product according to claim 1, characterized in that: The health product sample described in S1 is a solid preparation.

5. The gas chromatography-mass spectrometry detection method for sildenafil in a health product according to claim 1, characterized in that: The mass of the sample powder transferred to the clean extraction container in S2 is 10 mg.

6. The gas chromatography-mass spectrometry detection method for sildenafil in a health product according to claim 1, characterized in that: S2 The extraction solvent is a mixed solution of chloroform and methanol in a volume ratio of 9:

1.

7. The gas chromatography-mass spectrometry detection method for sildenafil in a health product according to claim 1, characterized in that: In S2, the volume of the extraction solvent added to the extraction container is 10 mL.

8. The gas chromatography-mass spectrometry detection method for sildenafil in a health product according to claim 1, characterized in that: The oscillation time of S2 is 10-15 minutes.

9. The gas chromatography-mass spectrometry detection method for sildenafil in a health product according to claim 1, characterized in that: The chromatographic column type of S3 is HP-5MS chromatographic column, and the chromatographic column parameters are 30m×0.25mm×0.25μm.

10. The gas chromatography-mass spectrometry detection method for sildenafil in a health product according to claim 1, characterized in that: During the gas chromatography-mass spectrometry detection process described in S3, 0.002 mg / mL of sildenafil standard solution was simultaneously analyzed for quality control.

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