Optimization method for applicability test of drug chromatography system

Abstract

The invention provides an optimization method for an applicability test of a drug chromatography system, and relates to the technical field of drug analysis, and provides a two-component solvent system, the two-component solvent system is composed of a polar solvent and a non-polar solvent, and the proportion of the two-component solvent system can be adjusted according to the chemical properties of a to-be-analyzed drug, and the ratio of the two-component solvent system to the non-polar solvent can be adjusted according to the chemical properties of the to-be-analyzed drug. The chemical properties include acid-base properties, polarity and functional group types. A normal phase chromatography stationary phase material is arranged, and operation parameters in a chromatography system are detected through a real-time monitoring system. The operating parameters are dynamically adjusted based on the real-time monitoring system. According to the optimization method for the applicability test of the medicine chromatographic system, by optimizing matching of a two-component solvent system and a normal-phase chromatographic stationary phase material, optimal separation can be achieved for different medicine molecules, the optimization method is suitable for medicines with complex chemical structures or large polarity differences, and the separation efficiency and the analysis precision are remarkably improved.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical analysis technology, specifically to an optimized method for suitability testing of a pharmaceutical chromatography system. Background Technology

[0002] Chromatographic system suitability testing is a crucial step in drug quality control, used to verify the stability and reliability of chromatographic methods. Currently, conventional methods mainly employ fixed-ratio mobile phase systems, such as acetonitrile-water or methanol-water mixtures, combined with common stationary phases like C18 for separation. Operating parameters are typically set to fixed values, with solvent ratios adjusted only through preset gradient programs. Some techniques utilize offline optimization, relying on multiple experiments to adjust method parameters. Column efficiency evaluation is based on theoretical plate number calculations under static conditions, and monitoring systems are primarily used for data acquisition rather than real-time control.

[0003] The core deficiency of existing technologies lies in the lack of a dynamic optimization mechanism, resulting in insufficient method adaptability. When analyzing drugs with different chemical properties, it is difficult to balance separation selectivity and analytical efficiency by fixing solvent ratios and static operating parameters. Especially for drug molecules with complex structures and large polarity differences, conventional methods are prone to problems such as peak tailing and insufficient resolution. Particularly when the analyte contains strongly polar groups or hydrophobic structures, existing technologies cannot achieve optimal separation in a single run, affecting the accuracy and reproducibility of analytical results. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides an optimization method for suitability testing of drug chromatography systems. The technical problem this invention aims to solve is: how to improve separation, reduce peak tailing, and enhance analytical accuracy and reproducibility when processing drugs with large polarity differences or complex molecular structures by dynamically adjusting operating parameters.

[0005] To achieve the above objectives, the present invention provides the following technical solution: an optimization method for suitability testing of a drug chromatography system, comprising: S1. providing a two-component solvent system, wherein the two-component solvent system is composed of two solvents, and the ratio of the two-component solvent system can be adjusted according to the chemical properties of the drug to be analyzed, wherein the chemical properties include acidity / basicity, polarity, and functional group type, and the two-component solvent system has optimized selectivity and separation capability, and can effectively separate drug molecules with complex chemical structures.

[0006] S2. Set a normal phase chromatography stationary phase material, wherein the stationary phase material is matched with the two-component solvent system, and the stationary phase material can provide the best separation effect for drug molecules with different chemical structures, and is suitable for the analysis of a variety of drug samples.

[0007] S3. The operating parameters in the chromatographic system are detected by a real-time monitoring system. The monitoring system can provide real-time feedback and record the changes in parameters during the separation process. The operating parameters include temperature and flow rate.

[0008] S4. Dynamically adjust the operating parameters based on the real-time monitoring system.

[0009] S5. Complete the suitability test and evaluate the performance indicators of the dynamically adjusted chromatographic system, including separation efficiency, column efficiency, and selectivity.

[0010] Preferably, the two-component solvent system includes a polar solvent and a non-polar solvent, wherein the polar solvent is acetonitrile, the non-polar solvent is n-hexane, the volume ratio of acetonitrile to n-hexane is 1:2 to 1:5, and this ratio can be automatically adjusted during chromatographic operation.

[0011] Preferably, the real-time monitoring system calculates the column efficiency in real time by detecting the performance indicators. The column efficiency is obtained by calculating the retention time of the drug peak and the baseline width. The column efficiency calculation formula is as follows:

[0012]

[0013] Where N is the column efficiency, t R For the retention time of the drug peak, w b This represents the baseline width of the drug peak.

[0014] Preferably, the real-time monitoring system adjusts the flow rate using an adaptive algorithm based on the column efficiency. The adaptive algorithm is as follows:

[0015]

[0016] Where v(t) is the adjusted flow velocity at time t, v0 is the initial flow velocity, α is the flow velocity adjustment coefficient, and N t Let N(t) be the target column efficiency value, and N(t) be the column efficiency value at the current moment.

[0017] Preferably, the normal phase chromatography stationary phase material is modified silica gel, which is treated with a coupling agent, wherein the coupling agent is an aminoalkylsilane, and the particle size of the normal phase chromatography stationary phase material is 5 μm and the pore size is [missing information].

[0018] Preferably, the real-time monitoring system also dynamically adjusts the solvent concentration of the two-component solvent system according to the performance indicators, and the solvent concentration change rate is related to a preset total gradient time, which is 5 minutes to 60 minutes.

[0019] Preferably, the real-time monitoring system optimizes the separation efficiency by using the temperature and the solvent concentration. The temperature and the solvent concentration are negatively correlated. When the temperature increases, the rate of change of the solvent concentration gradient is reduced accordingly. When the solvent concentration increases, the column temperature is reduced accordingly.

[0020] Preferably, the drug to be analyzed is a chemically synthesized drug, and the functional group types include aromatic rings, carboxyl groups, and amino groups.

[0021] This invention provides an optimized method for suitability testing of a pharmaceutical chromatography system. It offers the following advantages:

[0022] The optimized method employs dynamic adjustment of operating parameters and a real-time monitoring system to enhance the precision of drug chromatographic analysis. By optimizing the matching of the two-component solvent system and the stationary phase material in normal-phase chromatography, optimal separation can be achieved for different drug molecules. This method is suitable for drugs with complex chemical structures or significant polarity differences, significantly improving separation efficiency and analytical accuracy.

[0023] The optimization method for suitability testing of drug chromatography systems uses an adaptive algorithm to adjust flow rate and solvent concentration in real time, making the chromatography system more flexible and efficient in practical applications. This optimization method improves the reliability of chromatographic analysis, reduces human error during experiments, enhances the adaptability and repeatability of the chromatographic method, and ensures the accuracy and stability of drug analysis results. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the optimized method for suitability testing of a drug chromatography system;

[0025] Figure 2 This is a schematic diagram illustrating real-time monitoring and dynamic adjustment of operating parameters;

[0026] Figure 3 This is a schematic diagram of an adaptive algorithm adjusting the flow rate. Detailed Implementation

[0027] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] Example 1

[0029] like Figure 1-3As shown, this embodiment of the invention provides an optimization method for a suitability test of a drug chromatography system, comprising: S1. providing a two-component solvent system, the two-component solvent system being composed of two solvents, and the ratio of the two-component solvent system being adjustable according to the chemical properties of the drug to be analyzed, including acidity / basicity, polarity, and functional group type. The drug to be analyzed is a chemically synthesized drug, and the functional group type includes aromatic rings, carboxyl groups, and amino groups. The two-component solvent system includes a polar solvent and a non-polar solvent, the polar solvent being acetonitrile, and the non-polar solvent being n-hexane, the volume ratio of acetonitrile to n-hexane being 1:2 to 1:5.

[0030] S2. Setting the stationary phase material for normal phase chromatography. The stationary phase material for normal phase chromatography is modified silica gel, specifically an aminoalkylsilane, with a surface amino density of 0.8 μmol / m³. 2 -1.2 μmol / m 2 The particle size is 5μm and the pore size is

[0031] S3. The operating parameters in the chromatographic system are monitored in real time. The monitoring system can provide feedback and record changes in parameters during the separation process in real time. Operating parameters include temperature and flow rate. The real-time monitoring system optimizes separation efficiency by using temperature and solvent concentration. The changes in temperature and solvent concentration are negatively correlated. When the temperature increases, the rate of change of the solvent concentration gradient decreases accordingly. When the solvent concentration increases, the column temperature decreases accordingly.

[0032] S4. Dynamically adjust operating parameters based on the real-time monitoring system. The real-time monitoring system also dynamically adjusts the solvent concentration of the two-component solvent system according to performance indicators. The rate of change of solvent concentration is related to the preset total gradient time, which is 5-60 minutes.

[0033] S5. Complete the suitability test and evaluate the performance indicators of the dynamically adjusted chromatographic system, including separation efficiency, column efficiency, and selectivity. The real-time monitoring system calculates column efficiency in real time by detecting performance indicators. Column efficiency is obtained by calculating the retention time of the drug peak and the baseline width. The column efficiency calculation formula is:

[0034]

[0035] Where N is the column efficiency, t R For the retention time of the drug peak, w b This represents the baseline width of the drug peak.

[0036] The real-time monitoring system adjusts the flow rate using an adaptive algorithm based on column efficiency. The adaptive algorithm is as follows:

[0037]

[0038] Where v(t) is the adjusted flow velocity at time t, v0 is the initial flow velocity, α is the flow velocity adjustment coefficient, and N t Let N(t) be the target column efficiency value, and N(t) be the column efficiency value at the current moment.

[0039] Example 2

[0040] Unlike Example 1, this example focuses on how to optimize chromatographic separation by adjusting the solvent ratio.

[0041] 1. Selecting a solvent system

[0042] Based on the chemical properties of the drug, a suitable solvent system is selected. In this embodiment, considering the chemical properties of the drug to be analyzed, acetonitrile and n-hexane were selected as the two solvents in the two-component solvent system.

[0043] Acetonitrile, a polar solvent: suitable for separating highly polar drug molecules.

[0044] n-Hexane, a nonpolar solvent: suitable for separating hydrophobic drug molecules.

[0045] 2. Adjust the solvent ratio according to the properties of the drug.

[0046] The solvent ratio is adjusted according to the polarity and chemical properties of the drug to be analyzed. Assuming the drug to be analyzed is a moderately polar compound with functional groups including an aromatic ring and a carboxyl group, the selected solvent ratio is acetonitrile to n-hexane in a volume ratio of 1:3.

[0047] The initial solvent system ratio is acetonitrile: n-hexane = 1:3.

[0048] The volume of acetonitrile is 100 mL.

[0049] The volume of n-hexane is 300 mL.

[0050] This ratio is suitable for the separation of moderately polar drugs. A higher proportion of n-hexane can help improve the solubility of hydrophobic drug molecules.

[0051] 3. Automatically adjusts solvent ratio

[0052] During chromatographic analysis, the solvent ratio is automatically adjusted according to the chemical properties of the drug and the separation requirements. For example, if the analyte is highly polar, the system will automatically increase the proportion of acetonitrile to enhance the polarity of the solvent, thereby improving the separation effect.

[0053] Example of solvent ratio adjustment: If the system detects that the analyte has strong polarity during analysis, the system will automatically adjust the solvent ratio to acetonitrile:n-hexane = 1:2, that is:

[0054] The volume of acetonitrile is 200 mL.

[0055] The volume of n-hexane is 400 mL.

[0056] By dynamically adjusting the solvent ratio, the selectivity of the solvent system can be effectively enhanced, the separation effect can be optimized, and the problems of peak tailing and insufficient resolution can be reduced.

[0057] 4. Operation and Evaluation

[0058] After adjusting the solvent ratio, chromatographic separation was continued, and the following performance indicators were monitored and evaluated in real time:

[0059] Separation efficiency: assessed by the degree of separation of drug peaks.

[0060] Column efficacy: Column efficacy is evaluated by calculating the retention time of the drug peak and the baseline width.

[0061] Selectivity: Evaluating the separation selectivity between different drug molecules.

[0062] For example, with a solvent ratio of acetonitrile:n-hexane = 1:3, the separation efficiency is 95% and the column efficiency is 6400. With a solvent ratio of acetonitrile:n-hexane = 1:2, the separation efficiency is increased to 98% and the column efficiency is increased to 7000.

[0063] Data Summary:

[0064] Initial solvent ratio: Acetonitrile: n-hexane = 1:3 100mL acetonitrile + 300mL n-hexane.

[0065] Adjusted solvent ratio: Acetonitrile: n-hexane = 1:2 200mL acetonitrile + 400mL n-hexane.

[0066] Separation efficiency: Initial solvent ratio: 95%. Adjusted solvent ratio: 98%.

[0067] Column efficiency: Initial solvent ratio: 6400. Adjusted solvent ratio: 7000.

[0068] By dynamically adjusting the solvent system, the chromatographic separation process can be optimized according to the specific properties of the drug, thereby improving the accuracy and reliability of chromatographic analysis.

[0069] Example 3

[0070] This embodiment illustrates how selecting and optimizing modified silica gel as a stationary phase material in normal-phase chromatography can improve separation efficiency and column efficiency in chromatographic analysis, and reduce peak tailing.

[0071] 1. Selecting stationary phase materials

[0072] The stationary phase material in chromatographic analysis directly affects the separation efficiency. A suitable stationary phase material for normal phase chromatography should be selected based on the molecular structure and properties of the drug. Stationary phase material selection: Modified silica gel, due to its good surface chemical stability and separation selectivity, is suitable for most drug molecules, and is particularly suitable for drugs containing polar functional groups.

[0073] Particle size: 5μm silica particles were selected to provide higher separation efficiency.

[0074] Aperture: Select aperture as Silica gel is suitable for the separation of large molecule drugs.

[0075] 2. Set up the chromatographic column and fill it with stationary phase material.

[0076] Modified silica gel is packed into the chromatographic column. Using modified silica gel as the stationary phase material provides optimized separation performance for drugs containing polar groups.

[0077] 3. Optimize separation conditions

[0078] Optimize separation conditions to suit the analysis of different drugs. For the moderately polar drug to be analyzed, the following initial conditions are set:

[0079] Mobile phase system: a mixture of acetonitrile and water, with a volume ratio of acetonitrile to water of 1:1, used to improve drug separation efficiency.

[0080] Temperature: The initial temperature is set to 30℃.

[0081] Flow rate: The initial flow rate was set to 1.0 mL / min.

[0082] 4. Effectiveness of separating monitoring and optimization

[0083] By monitoring the performance indicators of the chromatography system in real time and adjusting the operating parameters based on feedback, the optimal chromatographic separation effect can be ensured.

[0084] Data Example:

[0085] Table 1: Data Comparison

[0086] parameter No modified silicone was used Use modified silicone stationary phase materials Regular silicone Modified silicone Column effect 5000 7000 Resolution 75％ 90％ Peak-shaped trail Obvious, peak shape asymmetry Slight, peak symmetrical

[0087] Results analysis:

[0088] By using modified silica gel as the stationary phase material, the chromatographic system achieved significant improvements in separation efficiency and column efficiency.

[0089] The column efficiency increased from 5500 to 7200, indicating a significant improvement in separation efficiency.

[0090] The resolution improved from 75% to 90%, indicating more precise separation between drug molecules and more symmetrical peak shapes.

[0091] Peak tailing was significantly reduced, and the accuracy and repeatability of the separation process were optimized.

[0092] By selecting and optimizing the use of modified silica gel as the stationary phase material for normal phase chromatography, the separation efficiency and column efficiency of chromatographic analysis are significantly improved, and peak tailing is reduced, thereby enhancing the reliability and reproducibility of chromatographic analysis.

[0093] Example 4

[0094] Unlike Example 1, this example describes how to dynamically adjust operating parameters based on real-time data to optimize chromatographic separation.

[0095] 1. Real-time monitoring of operating parameters

[0096] Temperature and flow rate are two key operating parameters in chromatographic analysis that affect separation efficiency, selectivity, and the morphology of drug peaks.

[0097] The real-time monitoring system continuously tracks and records these operating parameters to ensure that the chromatography system operates in optimal condition.

[0098] Assume the initial conditions are as follows:

[0099] Initial temperature: 30℃.

[0100] Initial flow rate: 1.0 mL / min.

[0101] Operating conditions: A standard C18 column was used, and the analyzed drug had moderate polarity.

[0102] 2. Real-time monitoring data

[0103] During the analysis, the real-time monitoring system records changes in temperature and flow rate and reports any deviations in the separation process.

[0104] Data example:

[0105] The real-time temperature monitoring showed a gradual increase from 30℃ to 32℃.

[0106] The real-time flow rate was adjusted from 1.0 mL / min to 1.2 mL / min.

[0107] Data analysis revealed that the initial settings for temperature and flow rate resulted in peak tailing and a decrease in separation.

[0108] 3. Adjust the temperature

[0109] Through real-time monitoring, the system detected the effect of temperature on drug separation in terms of peak tailing and separation efficiency. To optimize the separation effect, the temperature was gradually adjusted.

[0110] Adjusted temperature: The system increases the temperature from 30°C to 35°C, which helps reduce drug adhesion and improve separation efficiency.

[0111] 4. Adjust the flow rate

[0112] The real-time monitoring system observed the impact of flow rate changes on drug peak shape and separation. The system dynamically adjusts the flow rate to further optimize the separation effect.

[0113] Adjusted flow rate: The flow rate was adjusted from 1.0 mL / min to 1.2 mL / min, which helps to accelerate the separation process and reduce peak tailing.

[0114] Data Example:

[0115] By implementing real-time monitoring and dynamic adjustments, the system optimized the chromatographic process. The following is a comparison of data before and after the adjustment:

[0116] Initial settings:

[0117] Temperature: 30℃.

[0118] Flow rate: 1.0 mL / min.

[0119] Column efficacy: 6000.

[0120] Resolution: 80%.

[0121] Peak-shaped tail: obvious.

[0122] Adjusted settings:

[0123] Temperature: 35℃.

[0124] Flow rate: 1.2 mL / min.

[0125] Column efficacy: 7200.

[0126] Resolution: 90%.

[0127] Peak-shaped tail: slight.

[0128] By monitoring and dynamically adjusting operating parameters in real time, the performance of the chromatography system has been significantly improved:

[0129] The column efficiency has been increased from 6000 to 7200.

[0130] The separation efficiency was improved by 10%.

[0131] The peak tailing was significantly reduced, and the separation effect was improved.

[0132] By monitoring and dynamically adjusting operating parameters in real time, the performance of the chromatography system can be optimized, the efficiency of drug separation can be improved, and the reliability and accuracy of chromatographic analysis results can be ensured.

[0133] Example 5

[0134] Based on Example 1, this example describes how the suitability test of the drug chromatography system is completed by dynamically adjusting the operating parameters, and the final chromatographic performance is evaluated.

[0135] 1. Calculate column efficiency

[0136] The real-time monitoring system calculates column efficiency in real time by detecting performance indicators. Column efficiency is obtained by calculating the retention time of the drug peak and the baseline width. The formula for calculating column efficiency is:

[0137]

[0138] Where N is the column efficiency, t R For the retention time of the drug peak, w b This represents the baseline width of the drug peak.

[0139] Specific data:

[0140] t R =10min.

[0141] w b =0.5min.

[0142] Substitute the values:

[0143]

[0144] 2. Dynamically adjust operating parameters

[0145] 2.1 Flow rate adjustment

[0146] The real-time monitoring system uses an adaptive algorithm to adjust the flow rate based on the column efficiency. The adaptive algorithm adjusts the flow rate proportionally based on the difference between the current column efficiency and the target column efficiency. The adaptive algorithm is as follows:

[0147]

[0148] Where v(t) is the adjusted flow velocity at time t, v0 is the initial flow velocity, α is the flow velocity adjustment coefficient, and N t Let N(t) be the target column efficiency value, and N(t) be the column efficiency value at the current moment.

[0149] Specific data:

[0150] N(t) = 6400.

[0151] N t=8000.

[0152] v0 = 1.0 mL / min.

[0153] α = 0.5.

[0154] Substitute the data:

[0155]

[0156] The adjusted flow rate was 1.125 mL / min.

[0157] By using an adaptive adjustment method, the flow rate is increased, achieving a higher column efficiency target.

[0158] 2.2 Temperature Adjustment

[0159] Based on real-time monitoring, the system detected the impact of temperature on separation efficiency and adjusted the temperature to a higher value to optimize the separation degree.

[0160] Initial temperature: 30℃.

[0161] Adjusted temperature: 35℃.

[0162] Increased temperature can enhance the separation of polar drugs.

[0163] By dynamically adjusting operating parameters and optimizing the chromatographic system based on real-time monitoring feedback, column efficiency and resolution can be effectively improved, while peak tailing can be reduced. Through optimization, the accuracy and reliability of chromatographic analysis are enhanced, ensuring the high efficiency and stability of drug analysis results.

[0164] 3. Evaluate the performance indicators of the dynamically adjusted chromatographic system.

[0165] Separation efficiency:

[0166] For polar drugs, the proportion of polar solvents is increased to optimize separation efficiency.

[0167] For hydrophobic drugs, increasing the proportion of nonpolar solvents can improve separation efficiency.

[0168] Column effect:

[0169] By adjusting the flow rate and temperature, the flow rate of the drug can be adjusted, reducing peak tailing and improving column efficiency.

[0170] By using stationary phase materials such as modified silica gel, column efficiency can be improved, making it suitable for polar drugs.

[0171] Selectivity:

[0172] For drugs with complex chemical structures, selectivity can be improved by dynamically adjusting the solvent ratio.

[0173] When separating drugs of different polarities, optimize the solvent concentration gradient and adjust the separation process according to the specific properties of the drug.

[0174] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. An optimized method for suitability testing of a pharmaceutical chromatography system, characterized in that, include: S1. A two-component solvent system is provided, the two-component solvent system being composed of two solvents, and the ratio of the two-component solvent system can be adjusted according to the chemical properties of the drug to be analyzed, the chemical properties including acidity / basicity, polarity, and functional group type; S2. A normal-phase chromatography stationary phase material is provided, wherein the normal-phase chromatography stationary phase material and the two-component solvent system constitute a normal-phase chromatography system; S3. The operating parameters of the normal phase chromatography system are detected by a real-time monitoring system, the operating parameters including temperature and flow rate; S4. Dynamically adjust the operating parameters based on the real-time monitoring system; S5. Complete the suitability test and evaluate the performance indicators of the dynamically adjusted normal phase chromatography system, including separation efficiency, column efficiency, and selectivity.

2. The optimized method for suitability testing of a pharmaceutical chromatography system according to claim 1, characterized in that: The two-component solvent system includes a polar solvent and a non-polar solvent, wherein the polar solvent is acetonitrile, the non-polar solvent is n-hexane, and the volume ratio of acetonitrile to n-hexane is 1:2 to 1:

5.

3. The optimized method for suitability testing of a pharmaceutical chromatography system according to claim 1, characterized in that: The real-time monitoring system calculates the column efficiency in real time by detecting the performance indicators. The column efficiency is obtained by calculating the retention time of the drug peak and the baseline width. The formula for calculating the column efficiency is as follows: Where N is the column efficiency, t R For the retention time of the drug peak, w b This represents the baseline width of the drug peak.

4. The optimized method for suitability testing of a drug chromatography system according to claim 3, characterized in that: The real-time monitoring system adjusts the flow rate using an adaptive algorithm based on the column efficiency. The adaptive algorithm is as follows: Where v(t) is the adjusted flow velocity at time t, v0 is the initial flow velocity, α is the flow velocity adjustment coefficient, and N t Let N(t) be the target column efficiency value, and N(t) be the column efficiency value at the current moment.

5. The optimized method for suitability testing of a pharmaceutical chromatography system according to claim 1, characterized in that: The stationary phase material for normal phase chromatography is modified silica gel, specifically an aminoalkylsilane, with an amino group density of 0.8 μmol / m³ on its surface. 2 -1.2 μmol / m 2 Particle size of 5μm, pore size of 6. The optimized method for suitability testing of a pharmaceutical chromatography system according to claim 1, characterized in that: The real-time monitoring system also dynamically adjusts the solvent concentration of the two-component solvent system according to the performance indicators. The solvent concentration change rate is related to the preset total gradient time, which is 5 minutes to 60 minutes.

7. The optimization method for suitability testing of a pharmaceutical chromatography system according to claim 1, characterized in that: The real-time monitoring system optimizes the separation efficiency by using the temperature and the solvent concentration, and the changes in temperature and solvent concentration are negatively correlated.

8. The optimized method for suitability testing of a pharmaceutical chromatography system according to claim 1, characterized in that: The drug to be analyzed is a chemically synthesized drug, and the functional group types include aromatic rings, carboxyl groups, and amino groups.

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