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Method for detecting content of impurity C in gliquidone

A technology for gliquidone and impurities, applied in the field of drug analysis, can solve the problems of ineffective detection of impurity C, serious adverse reactions, and toxicity, and achieve the effects of ensuring drug safety, clear principles, and improving quality standards

Pending Publication Date: 2021-06-08
TIANJIN INSTITUTE OF PHARMA RESEARCH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Impurity C was detected by the methods of Chinese Pharmacopoeia and British Pharmacopoeia, and there was no response, indicating that the methods of Chinese Pharmacopoeia and British Pharmacopoeia could not effectively detect impurity C. No quantitative detection method for impurity C in gliquidone is disclosed
[0010] There is no relevant toxicity research data on impurity C in the literature at home and abroad. In the absence of toxicity research data to support its harmlessness to the human body, the existence of impurity C may cause serious adverse reactions or even toxicity

Method used

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  • Method for detecting content of impurity C in gliquidone
  • Method for detecting content of impurity C in gliquidone
  • Method for detecting content of impurity C in gliquidone

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] 1. Instruments and testing conditions

[0037] The Agilent 1260 high-performance liquid chromatograph produced by U.S. Agilent Corporation, the AgilentZORBAX Eclipse Plus C18 chromatographic column produced by Agilent; Detection wavelength is 210nm; Mobile phase: methyl alcohol: phosphate aqueous solution (phosphate aqueous solution pH value is 4.5), in 20 minutes The internal temperature was changed from 45:55 to 70:30; the flow rate was 1ml / min; the column temperature of the chromatographic column was 35°C; the injection volume was 20μl.

[0038] 2. Experimental steps

[0039] Take an appropriate amount of the mixture composed of gliquidone, impurity C, impurity A, impurity G, impurity J and impurity L, add methanol to dissolve, and prepare a mixed solution containing 5mg gliquidone and 0.05mg of each impurity per 1ml; Liquinone and the standard substances of various impurities were prepared into positioning solution as a control. Get the blank solution, the mixed s...

Embodiment 2

[0041] 1. Instruments and testing conditions

[0042] The Agilent 1260 high-performance liquid chromatograph produced by U.S. Agilent Company, the AgilentZORBAX Eclipse Plus C18 chromatographic column produced by Agilent; The detection wavelength is 210nm; Mobile phase: acetonitrile: aqueous acetate solution (the pH value of aqueous acetate solution is 4.5), in Change from 45:55 to 70:30 within 18 minutes; the flow rate is 1ml / min; the column temperature of the chromatographic column is 35°C; the injection volume is 20μl.

[0043] 2. Experimental steps

[0044] Take an appropriate amount of impurity C, add methanol to dissolve, and prepare a solution containing 1 μg of impurity C per 1 ml, as the limit of quantitation solution, prepare 2 copies in parallel; take an appropriate amount of impurity C, add methanol to dissolve, and prepare a solution containing 0.3 μg of impurity C per 1 ml , as the limit of detection solution, prepare 2 parts in parallel. Sampling was carried o...

Embodiment 3

[0048] 1. Instruments and testing conditions

[0049] The Agilent 1260 high-performance liquid chromatograph produced by U.S. Agilent Corporation, the AgilentZORBAX Eclipse Plus C18 chromatographic column produced by Agilent; Detection wavelength is 210nm; Mobile phase: methyl alcohol: phosphate aqueous solution (phosphate aqueous solution pH value is 4.5), in 20 minutes The internal temperature was changed from 40:60 to 65:35; the flow rate was 1ml / min; the column temperature of the chromatographic column was 35°C; the injection volume was 20μl.

[0050] 2. Experimental steps

[0051] Take an appropriate amount of impurity C, add methanol to dissolve, prepare a solution containing 40 μg of impurity C per 1 ml, and dilute it to a linear solution of different concentrations, and then inject samples for determination. The results showed that the impurity C had a good linear relationship within the concentration range of 1-40 μg / ml. The experimental results are shown in Table 2...

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Abstract

The invention provides a method for detecting the content of impurity C in gliquidone. The detection method adopts high performance liquid chromatography. The detection method provided by the invention has relatively high specificity, sensitivity and accuracy, is simple and convenient to operate, can be used for quickly and accurately detecting the content of the impurity C in the gliquidone, can be used for detecting related substances of the gliquidone, improves the quality standard of the gliquidone by taking the impurity C as a known impurity to be bound into a related substance detection item of the gliquidone, and ensures the medication safety.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a method for measuring the content of impurity C in gliquidone. Background technique [0002] Gliquidone is the second-generation oral sulfonylurea hypoglycemic drug, which is a highly active pro-islet β-cell agent. It binds to specific receptors on the islet β-cell membrane and can induce the production of an appropriate amount of insulin to reduce blood sugar concentration. The highest plasma concentration is reached after 2-2.5 hours of oral administration of this product, and it will be completely absorbed soon. The plasma half-life is 1.5 hours, and the metabolism is complete. Its metabolites have no hypoglycemic effect, and most of the metabolites are excreted through the biliary tract. [0003] Its main synthesis route is as follows: [0004] [0005] The Chinese Pharmacopoeia’s detection method for related substances of gliquidone is as follows: use...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89G01N30/06G01N30/54
CPCG01N30/89G01N30/06G01N30/54
Inventor 康江鹏雷勇胜丁文宇陈蔚潘毅
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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