Method for detecting residual quantity of NVP in disposable drainage catheter

Abstract

The invention belongs to the technical field of detection, and particularly relates to a method for detecting the residual quantity of NVP in a disposable drainage catheter. The invention provides a method for detecting the residual quantity of NVP in a disposable drainage catheter. The method comprises the following steps: preparing a to-be-detected sample solution; preparing a standard solution; detection conditions are set as follows: a detection instrument is an ultra-high performance liquid chromatograph-PDA detector, and a chromatographic column is ACQUITY UPLC HSS T3, 2.1 mm * 100 mm, 1.8 [mu] m; and detection: detecting the to-be-detected sample solution and the standard solution. The detection method provided by the invention adopts a multi-extraction mode, so that the target object in the sample can be completely detected as far as possible, the detection error is avoided, and the stability of the detection result is ensured.

Description

Technical Field

[0001] The invention belongs to the field of detection technology, and specifically relates to a method for detecting the residual amount of NVP in a disposable drainage catheter. Background Art

[0002] NVP (N-vinyl pyrrolidone) is a monomer compound for synthesizing povidone K30 polymer. During the synthesis process, a small amount of N-vinyl pyrrolidone will inevitably fail to form a chain, or be decomposed by povidone into monomer N-vinyl pyrrolidone. Since the synthesis process cannot completely convert N-vinyl pyrrolidone into povidone K30 polymer, the content of N-vinyl pyrrolidone in povidone K30 polymer needs to be controlled within a certain range according to the 2020 edition of the Chinese Pharmacopoeia. According to some existing reports, polymers can enter the human body directly or indirectly through the use of their monomers in specific products (such as food contact materials, medical devices, cosmetics, pharmaceuticals, building materials and toys), which may pose a threat to humans. The International Agency for Research on Cancer classifies NVP as a Class 3 carcinogen, which means it is a possible carcinogen to humans, and the substance is a substance of concern specified in the Toxic Substances Control Act (TSCA) list of the U.S. Environmental Protection Agency EPA.

[0003] In order to further determine the residual amount of NVP in disposable drainage catheters and ensure that unnecessary harm is reduced when people use disposable drainage catheters, it is very important to develop a rapid method for detecting the residual amount of NVP in the current period of concern for human development and health. Summary of the invention

[0004] In order to solve the above technical problems, the first aspect of the present invention provides a method for detecting the residual amount of NVP in a disposable drainage catheter, which specifically comprises the following steps:

[0005] Preparation of the sample solution to be tested: taking the sample to be tested, adding it to the leaching solvent after pretreatment, leaching for 12 to 36 hours, completing the first leaching, and obtaining the first leaching solution; repeating the leaching operation ≥1 times to obtain the limit leaching solution; the first leaching solution and the limit leaching solution are both the sample solutions to be tested;

[0006] Preparation of standard solution: Weigh the NVP standard and prepare the standard solution;

[0007] Detection conditions: Detection instrument: ultra-high performance liquid chromatography-PDA detector, chromatographic column: ACQUITY UPLCHSS T3, 2.1 mm × 100 mm, 1.8 μm;

[0008] Detection: Test the sample solution and the standard solution.

[0009] The target substance concentration in the limiting extract is ≤ 10% of the target substance concentration in the first extract;

[0010] In some preferred embodiments, the pretreatment includes shearing the sample to be tested.

[0011] In some preferred embodiments, the shearing treatment requires that the sample to be tested is sheared into a sample of 10 mm×50 mm.

[0012] In some preferred embodiments, the leaching solvent includes but is not limited to purified water.

[0013] The extraction solvent may include purified water, alcohol solvents, ester solvents, and the like.

[0014] Further preferably, the extraction solvent comprises purified water.

[0015] In some preferred embodiments, the extraction is performed ≥ 1 times.

[0016] In some preferred embodiments, the number of extractions is determined by the concentration of the target substance in the extract.

[0017] More preferably, the solution obtained by the last leaching is a limit leaching solution.

[0018] In some preferred embodiments, three groups of the extreme extracts are prepared simultaneously and in the same manner.

[0019] In some preferred embodiments, a blank sample solution is further prepared. The blank sample solution is prepared in the same manner as the test sample solution, except that the test sample is not added during the preparation process.

[0020] In some preferred embodiments, the target substance concentration in the limiting leaching solution is ≤ 10% of the target substance concentration in the first leaching solution.

[0021] The detection method provided in this application uses purified water for extraction instead of organic solvents, thereby avoiding the influence of organic solvents on the detection results. In addition, an extreme extraction method and multiple extractions are used to ensure that all target objects in the sample are detected. The test data has high precision and accuracy, and the reproducibility of the test results is good.

[0022] In some preferred embodiments, the extraction operation is: dynamic shaking at 37° C., an oscillation frequency of 60 rpm, and extraction for 24 hours.

[0023] In some preferred embodiments, the preparation of the standard solution specifically includes the following steps: weighing the NVP standard into a volumetric flask, adding purified water to dilute to the scale, and shaking well; and then preparing a standard solution of a specific concentration.

[0024] Further preferably, the preparation of the standard solution specifically includes the following steps: weigh 10.00 mg NVP standard into a 10 mL volumetric flask, add purified water to dilute to the scale, and shake well; then transfer 1000 μL of the above solution into a new 10 mL volumetric flask, add purified water to dilute to the scale, and shake well to obtain a standard solution with a concentration of 100.0 μg / mL.

[0025] In some preferred embodiments, the obtained standard solution is diluted to prepare solutions of different concentrations, and a standard curve is drawn. The specific dilution method of the solution configuration involved in the standard curve drawing process and the concentration of the obtained standard curve solution are specifically shown in Tables 1 and 2 below:

[0026] Table 1 Standard curve solution preparation table

[0027]

[0028] Note: Table 1 is diluted to final volume with purified water.

[0029] Table 2 Concentration of each solution in the standard curve

[0030]

[0031] In some preferred embodiments, the detection condition setting includes the selection of a detection instrument and the determination of detection conditions.

[0032] Further preferably, the detection instrument comprises an ultra-high performance liquid chromatograph-PDA detector (UPLC-PDA).

[0033] In some preferred embodiments, the detection conditions include the selection of a chromatographic column, and the chromatographic column is ACQUITY UPLC HSS T3, 2.1 mm×100 mm, 1.8 μm.

[0034] In some preferred embodiments, the detection conditions include flow rate, analysis time, injection volume, column temperature, sample chamber temperature, mobile phase, scanning wavelength range, and detection wavelength.

[0035] Further preferably, the flow rate includes 0.1mL / min to 1mL / min, which can be listed as 0.1mL / min, 0.155mL / min, 0.185mL / min, 0.2mL / min, 0.255mL / min, 0.275mL / min, 0.3mL / min, 0.335mL / min, 0.365mL / min, 0.4mL / min, 0.42mL / min, 0.465mL / min, 0.495mL / min, 0.5mL / min, 0.555mL / min, 0.575mL / min, 0.6mL / min, 0.625mL / min, 0.645mL / min, 0.685mL / min, 0.7mL / min, 0.735mL / min, 0.785mL / min, 0.8mL / min, 0.855mL / min, 0.9mL / min and the like.

[0036] In some preferred embodiments, the analysis time is 1 to 10 min, and examples thereof include 1 min, 2 min, 3 min, 4 min, 5 min, 6 min, 7 min, 8 min, 9 min, and 10 min.

[0037] In some preferred embodiments, the injection volume includes 1 to 20 μL, which can be listed as 1 μL, 2 μL, 3 μL, 4 μL, 5 μL, 6 μL, 7 μL, 8 μL, 9 μL, 10 μL, 11 μL, 12 μL, 13 μL, 14 μL, 15 μL, 16 μL, 17 μL, 18 μL, 19 μL, and 20 μL.

[0038] In some preferred embodiments, the column temperature can be any temperature that can complete the operation, specifically 30°C, 35°C, etc.

[0039] The sample chamber temperature can be any conventional temperature that meets the requirements. The temperature that can be used in this application includes 15°C.

[0040] In some preferred embodiments, the fluidity includes mobile phase A and mobile phase B; the mobile phase A is purified water; and the mobile phase B is acetonitrile.

[0041] In some preferred embodiments, the volume ratio of the mobile phase A to the mobile phase B is 90:10.

[0042] In some preferred embodiments, the scanning wavelength range is 190 nm to 400 nm.

[0043] In some preferred embodiments, the detection wavelength is 195 nm.

[0044] In some preferred embodiments, the specific steps of the detection include: after setting the detection conditions, injecting the sample to be tested into an ultra-high performance liquid chromatograph-PDA detector for analysis and detection.

[0045] This application innovatively uses an ultra-high performance liquid chromatograph-PDA detector for NVP residual detection in disposable drainage catheters. Through the adjustment of test conditions and multiple exploratory experiments, it is found that the NVP residual test can be completed within 3 minutes, and the accuracy and precision RSD of the test results are both 0%, proving that the detection method provided by this application can complete the NVP residual detection, and the detection method is stable. After the sample is placed for 24 hours and tested again, the RSD can still reach 1%. The method provided by this application is simple, fast, and efficient, and can be widely used for the detection of substances harmful to humans, and has great application value.

[0046] In order to further avoid test errors and ensure the accuracy and precision of the test results, it is necessary to prepare the quantitative limit spike solution before testing.

[0047] In some preferred embodiments, the quantitative limit spike solution is prepared by measuring 1000 μL of the sample solution to be tested into a 10 mL volumetric bottle, adding 3.00 μL of NVP standard solution, diluting to the scale with the sample solution to be tested, shaking well, and setting aside.

[0048] When testing, take 1 mL of the quantitative limit spike solution into a liquid phase injection bottle for testing.

[0049] A total of 3 quantitation limit spiked solutions were prepared in parallel using the same method, and low concentration level accuracy solution 1 to low concentration level accuracy solution 3 were obtained respectively.

[0050] Beneficial Effects

[0051] 1. The detection method provided by the present invention can be used to detect the residual amount of organic matter NVP in disposable drainage tubes. The detection time can be completed within 3 minutes. The RSD of the precision and accuracy of the detection results are both 0%, indicating that the results of this method are true and reliable and can be widely used.

[0052] 2. The detection method provided by the present invention adopts a multiple extraction method, which can ensure that the target objects in the sample are detected as completely as possible, avoid detection errors, and ensure the stability of the detection results.

[0053] 3. The detection method provided by the present invention uses purified water for extraction and also uses purified water as fluidity. After multiple elutions with purified water, the perfect peak of NVP is ensured during detection, thereby ensuring the reliability of the detection results.

[0054] 4. The detection method provided by the present invention uses purified water as the extraction solvent, avoiding the use of organic solvents, and further avoiding the influence of organic solvents on the NVP peak. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] Figure 1 This is the peak diagram of the reagent blank solution in Example 1 of the present application;

[0056] Figure 2 This is the peak diagram of the standard curve solution in Example 1 of the present application;

[0057] Figure 3 This is the peak diagram of the blank sample solution in Example 1 of the present application;

[0058] Figure 4 This is the peak diagram of the sample solution to be tested in Example 1 of the present application;

[0059] Figure 5 This is the peak diagram of the quantitative limit spiked solution of Example 1 of the present application;

[0060] Figure 6 This is the regression equation diagram of the standard solution in Example 1 of the present application. DETAILED DESCRIPTION

[0061] The shearing of the sample to be tested in this application is carried out in accordance with GB / T 16886.12;

[0062] The disposable drainage catheter kit used in this application is from Henan Tuoren Best Medical Instrument Co., Ltd., with a specification of 13Fr-2 and a sample number of BP-S-24054608.

[0063] In this field, the correlation coefficient of the regression equation should not be greater than 0.99, which means that the accuracy of the experimental results is relatively high.

[0064] In this field, the relative standard deviation (RSD) of experimental data of content determination is within 15%, indicating that the experimental results are reliable and can truly reflect the content of a substance.

[0065] In this field, the sample recovery rate is within the range of 75% to 125%, indicating that there are no abnormal links in the experimental process, the established method meets the requirements of content determination, and the experimental results obtained are reliable.

[0066] The present application will be further described below in conjunction with embodiments.

[0067] Example 1

[0068] (1) Preparation of sample solution

[0069] Take a disposable drainage tube kit, take the contact component as the sample to be tested, shear the sample to be tested (refer to GB / T 16886.12) to obtain a 10 mm × 50 mm sample, put it into a polytetrafluoroethylene bottle, add purified water to completely immerse the sample, cover it with a lid, and dynamically shake it at 60 rpm for 24 hours at 37°C to obtain the first extract;

[0070] After the first extraction is completed, the sample is taken out from the first extraction solution and placed in a new polytetrafluoroethylene bottle, and the same extraction operation is repeated to obtain a second extraction solution;

[0071] The extraction operation is repeated successively until the concentration of the target substance (NVP) in the extract is ≤10% of the NVP concentration in the first extract, and the limit extraction is completed to obtain the limit extract. The first extract to the limit extract are all the sample solutions to be tested in this embodiment.

[0072] In this embodiment, the samples to be tested need to be prepared at the same time, and three groups of sample solutions to be tested are prepared in the same way.

[0073] (2) Preparation of blank sample solution

[0074] Prepare blank sample solution according to the method of preparing the sample solution to be tested and set aside.

[0075] (3) Preparation of standard solution

[0076] Weigh 10.00 mg of NVP standard into a 10 mL volumetric flask, add purified water to dilute to the mark, and shake well.

[0077] Pipette 1000 μL of the shaken solution into another 10 mL volumetric flask, add purified water to dilute to the mark, and shake well to obtain a standard solution with a concentration of 100.0 μg / mL.

[0078] (3) Standard curve solution preparation

[0079] Measure a specific amount of standard solution and place it in a 10mL volumetric flask. Add purified water to dilute to the scale line, shake well, and prepare a standard curve solution. The specific amount and concentration are shown in Label 1 and Table 2.

[0080] (4) Setting of testing conditions:

[0081] In this embodiment, an ultra-high performance liquid chromatograph-PDA detector is used to detect the NVP residue in the sample to be tested. The method is detailed in Table 3 below:

[0082] Table 3 Parameter settings of UPLC-PDA detector

[0083]

[0084]

[0085] In this embodiment, the test gradient table is shown in Table 4 below:

[0086] Table 4 Test gradient table

[0087]

[0088] (5) Testing:

[0089] The prepared sample solution to be tested, blank sample solution, reagent blank solution, standard curve solution (L-3), and quantitative limit spike solution were injected into the ultra-high performance liquid chromatography-PDA detector for detection.

[0090] Test Results

[0091] Note: For solution preparation involved in the test process, if there is no special instruction, when using the sample solution to be tested, the sample solution to be tested uses the first extraction solution.

[0092] (1) Exclusivity

[0093] Judging criteria:

[0094] There shall be no interference near the peak position of the target substance in the reagent blank solution, standard curve solution (L-3), blank sample solution, sample solution to be tested and quantitative limit spiked solution, or the separation between the target peak and the interference peak shall not be less than 1.5; the measured value of the target substance in the reagent blank solution shall not be greater than 1 / 3 of the quantitative limit.

[0095] according to Figure 1-5 The displayed test results show that the reagent blank solution, standard curve solution (L-3), blank sample solution, test sample solution and quantitative limit spike solution have no interference near the peak position of the target substance.

[0096] (2) Linear verification

[0097] Judging criteria:

[0098] Linearity verification was performed based on the standard curve solution. The results are shown in Figure 6 ,according to Figure 6 The displayed content can be obtained, and the correlation coefficient is 0.999, which meets the requirements.

[0099] (3) Limit of quantification

[0100] Judging criteria:

[0101] Prepare the quantitation limit spike solution with the concentration of the quantitation limit solution as the spike level, 10% limit or less. The signal-to-noise ratio of the target substance in the quantitation limit solution shall not be less than 10; the recovery rate of the target substance in the quantitation limit spike solution shall be between 70% and 125%; the RSD of the recovery rate of the target substance in the quantitation limit spike solution shall not be greater than 15%.

[0102] The specific method for preparing the quantitative limit spike solution is as follows:

[0103] Measure 1000 μL of the sample solution to be tested into a 10 mL volumetric flask, add 3.00 μL of NVP standard solution, dilute to the scale with the sample solution to be tested, shake well, and set aside. Quantitation limit spike solution 1, quantitation limit spike solution 2, and quantitation limit spike solution 3 refer to three parallel solutions prepared simultaneously using the same method.

[0104] When testing, take 1 mL of the quantitative limit spike solution into a liquid phase injection bottle for testing.

[0105] The acceptance criteria and test results of the quantitative limit solution are shown in Table 5 below, and the acceptance criteria and results of the quantitative limit spike solution are shown in Table 6. It can be seen from Table 6 that the signal-to-noise ratio and recovery rate meet the standard requirements.

[0106] Table 5: Acceptance criteria and results for limit of quantitation

[0107]

[0108] Table 6: Acceptance criteria and results for the quantitation limit spike solution

[0109]

[0110]

[0111] (4) Detection limit

[0112] Judging criteria:

[0113] The signal-to-noise ratio of the detection limit solution must not be less than 3. The acceptance criteria and results of the quantitative limit spiked solutions (low, medium and high concentrations) are shown in Table 7. It can be seen from Table 7 that the signal-to-noise ratio of the detection limit solution is greater than 3.

[0114] The specific configuration methods of the three concentrations of the quantitative limit spike solution, low, medium and high, are as follows:

[0115] Low concentration level accuracy solutions:

[0116] Measure 1000 μL of the sample solution to be tested into a 10 ml volumetric flask, add 3.00 μL of NVP standard solution, dilute to the scale with the sample solution to be tested, shake well, and when testing, take about 1 mL of the solution into a liquid phase injection bottle.

[0117] A total of 3 solutions were prepared in parallel using the same method to obtain low concentration level accuracy solution 1 to low concentration level accuracy solution 3, respectively.

[0118] Medium concentration level accuracy solution

[0119] Measure 1000 μL of the sample solution to be tested into a 10 ml volumetric flask, add 30.0 μL of NVP standard solution, dilute to the scale with the sample solution to be tested, shake well, and when testing, take about 1 mL of the solution into a liquid phase injection bottle.

[0120] A total of 3 solutions were prepared in parallel using the same method to obtain medium concentration level accuracy solution 1 to medium concentration level accuracy solution 3, respectively.

[0121] High concentration level accuracy solutions

[0122] Measure 1000 μL of the sample solution to be tested into a 10 ml volumetric flask, add 45.0 μL of NVP standard solution, dilute to the scale with the sample solution to be tested, shake well, and when testing, take about 1 mL of the solution into a liquid phase injection bottle.

[0123] A total of 3 solutions were prepared in parallel using the same method to obtain high concentration horizontal accuracy solution 1 to high concentration horizontal accuracy solution 3, respectively.

[0124] The acceptance criteria and results of the signal-to-noise ratio-1, signal-to-noise ratio-2, and signal-to-noise ratio-3 of the low concentration level accuracy solution, the medium concentration level accuracy solution, and the high concentration level accuracy solution are shown in Table 7. It can be seen from Table 7 that the signal-to-noise ratio of the detection and quantification limit solution is greater than 3.

[0125] Table 7: Acceptance criteria and results for the quantitation limit spike solution

[0126]

[0127] (5) Accuracy verification

[0128] Prepare three accuracy solutions at three concentration levels (quantitation limit, 100% limit or below, 150% limit or below or 80% sample measured value, 100% sample measured value, 120% sample measured value), and prepare three parallel samples for each concentration. The specific configuration method is:

[0129] Low concentration level accuracy solutions:

[0130] Measure 1000 μL of the sample solution to be tested into a 10 ml volumetric flask, add 3.00 μL of NVP standard solution, dilute to the scale with the sample solution to be tested, shake well, and when testing, take about 1 mL of the solution into a liquid phase injection bottle.

[0131] A total of 3 solutions were prepared in parallel using the same method to obtain low concentration level accuracy solution 1 to low concentration level accuracy solution 3, respectively.

[0132] Medium concentration level accuracy solution

[0133] Measure 1000 μL of the sample solution to be tested into a 10 ml volumetric flask, add 30.0 μL of NVP standard solution, dilute to the scale with the sample solution to be tested, shake well, and when testing, take about 1 mL of the solution into a liquid phase injection bottle.

[0134] A total of 3 solutions were prepared in parallel using the same method to obtain medium concentration level accuracy solution 1 to medium concentration level accuracy solution 3, respectively.

[0135] High concentration level accuracy solutions

[0136] Measure 1000 μL of the sample solution to be tested into a 10 ml volumetric flask, add 45.0 μL of NVP standard solution, dilute to the scale with the sample solution to be tested, shake well, and when testing, take about 1 mL of the solution into a liquid phase injection bottle.

[0137] A total of 3 solutions were prepared in parallel using the same method to obtain high concentration horizontal accuracy solution 1 to high concentration horizontal accuracy solution 3, respectively.

[0138] Judgment criteria

[0139] The recovery rate of the target substance is between 70% and 125%; the RSD of the recovery rate of the target substance shall not be greater than 15%.

[0140] The concentrations of the three different sample solutions are shown in Table 8, and the accuracy acceptance criteria and results are shown in Table 9. As shown in Table 9, the recovery rate is 100% and the RSD is 0%.

[0141] Table 8: Concentrations of 3 different sample solutions

[0142]

[0143] Table 9: Accuracy acceptance criteria and results

[0144]

[0145] (6) Precision (repeatability)

[0146] Judgment criteria

[0147] Prepare 6 accuracy solutions with a concentration level of 100% limit or below in parallel (the specific preparation method includes: measuring 1000μL of the sample solution to be tested into a 10mL volumetric bottle, adding 30.0μL of NVP standard solution, diluting to the scale with sample mother solution, and shaking well; when testing, take about 1mL of the solution into a liquid phase injection bottle. Prepare a total of 6 solutions in parallel using the same method, and obtain repeatability solution 1 to repeatability solution 6 in turn), and the RSD of the 6 measured values ​​shall not be greater than 15%.

[0148] The acceptance criteria and results of repeatability are shown in Table 10. It can be seen from Table 10 that the RSD is 0%.

[0149] Table 10: Repeatability acceptance criteria and results

[0150]

[0151]

[0152] (7) Precision (intermediate precision)

[0153] Judgment criteria

[0154] (Different days, different people, different instruments) At least two, prepare 6 intermediate precision solutions with a spike concentration of 100% limit or less, as follows:

[0155] The samples were prepared by different analysts at different times (different days) and injected and analyzed on the same instrument.

[0156] Measure 1000 μL of the sample solution to be tested into a 10 mL volumetric flask, add 30.0 μL of NVP standard solution, dilute to the scale with the sample solution to be tested, and shake well; when testing, take 1 mL of the above-prepared solution into a liquid phase injection bottle.

[0157] A total of 6 solutions were prepared in parallel using the same method, and intermediate precision solution 1 to intermediate precision solution 6 were obtained in turn.

[0158] The RSD of the measured concentrations of the 6 intermediate precision solutions shall not be greater than 22%.

[0159] The intermediate precision acceptance criteria and results are shown in Table 11. As can be seen from Table 11, the RSD is 1%.

[0160] Table 11: Intermediate precision acceptance criteria and results

[0161]

[0162] (8) Stability

[0163] Judgment criteria

[0164] For the repeatability solution after 24 hours of standing, the RSD of the measured concentrations of the 6 solution stability solutions shall not be greater than 22%.

[0165] The solution stability acceptance criteria and results are shown in Table 12, from which it can be seen that the RSD is 1%.

[0166] Table 12: Solution Stability Acceptance Criteria and Results

[0167]

[0168] (9) Durability

[0169] Judgment criteria

[0170] Change the flow rate of the chromatographic column and inject 6 injections of the standard curve solution (L-3 solution) continuously. The RSD shall not be greater than 6%.

[0171] The flow rates of the chromatographic columns were set to 0.27 mL / min and 0.33 mL / min, respectively. The specific results are shown in Tables 13 and 14. As can be seen from Tables 13 and 14, the RSDs are both 1%.

[0172] Table 13: Column flow rate is 0.27 mL / min

[0173]

[0174] Table 14: Column flow rate is 0.33 mL / min

[0175]

[0176]

[0177] Through the above verification, it can be obtained that the precision, accuracy and stability of the detection scheme provided by the present invention all indicate that the scheme established in this application meets the requirements of content determination, and the experimental results obtained are reliable.

Claims

1. A method for detecting the residual amount of NVP in a disposable drainage catheter, characterized in that: The following steps are involved: Preparation of the sample solution to be tested: taking the sample to be tested, adding it to the leaching solvent after pretreatment, leaching for 12 to 36 hours, completing the first leaching, and obtaining the first leaching solution; repeating the leaching operation ≥1 times to obtain the limit leaching solution; the first leaching solution and the limit leaching solution are both the sample solutions to be tested; Preparation of standard solution: Weigh the NVP standard and prepare the standard solution; Detection conditions: Detection instrument: ultra-high performance liquid chromatography-PDA detector, chromatographic column: ACQUITY UPLC HSST3, 2.1 mm × 100 mm, 1.8 μm; Detection: Test the sample solution and the standard solution.

2. The method for detecting the residual amount of NVP in a disposable drainage catheter according to claim 1, characterized in that: The target substance concentration in the limiting leaching solution is ≤ 10% of the target substance concentration in the first leaching solution.

3. The method for detecting the residual amount of NVP in a disposable drainage catheter according to claim 1, characterized in that: The pretreatment includes performing shearing treatment on the sample to be tested.

4. The method for detecting the residual amount of NVP in a disposable drainage catheter according to claim 1 or 2, characterized in that: The leaching solvent includes purified water.

5. The method for detecting residual NVP in a disposable drainage catheter according to claim 1, characterized in that: The preparation of the standard solution specifically includes the following steps: weighing the NVP standard into a volumetric flask, adding purified water to dilute to the scale line, and shaking well; and then preparing a standard solution of a specific concentration.

6. The method for detecting the residual amount of NVP in a disposable drainage catheter according to claim 1, characterized in that: The detection conditions include flow rate, analysis time, injection volume, column temperature, sample chamber temperature, mobile phase, scanning wavelength range, and detection wavelength.

7. The method for detecting the residual amount of NVP in a disposable drainage catheter according to claim 6, characterized in that: The fluidity includes mobile phase A and mobile phase B; the mobile phase A is purified water; and the mobile phase B is acetonitrile.

8. The method for detecting residual NVP in a disposable drainage catheter according to claim 6, characterized in that: The flow rate includes 0.1 mL / min to 1 mL / min.

9. The method for detecting residual NVP in a disposable drainage catheter according to claim 1, characterized in that: Blank sample solution preparation is also included.

10. An application of the method for detecting NVP residue in a disposable drainage catheter according to any one of claims 1 to 9, characterized in that: Used for NVP detection in products that come into contact with humans.

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