Analysis method for determining 2-chlorophenylglycine methyl ester tartrate and impurities

A technology of o-chlorophenylglycine methyl ester and tartrate, which is applied in the field of pharmaceutical analysis, can solve problems such as difficult removal of impurities, and achieve high sensitivity, good repeatability, and good durability

Pending Publication Date: 2022-05-27
苏州正济医药研究有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, the quality control of clopidogrel bisulfate is included in the Pharmacopoeia, but there is no published detection method for the impurity control of phenylglycine methyl ester and m-chlorophenylglycine methyl ester in o-chlorophenylglycine methyl ester tartrate, and in the follow-up process Among them, the above two impurities are difficult to remove

Method used

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  • Analysis method for determining 2-chlorophenylglycine methyl ester tartrate and impurities
  • Analysis method for determining 2-chlorophenylglycine methyl ester tartrate and impurities
  • Analysis method for determining 2-chlorophenylglycine methyl ester tartrate and impurities

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] High Performance Liquid Chromatograph: Agilent 1260 Detector

[0041] Mobile phase: A: 0.1% phosphoric acid aqueous solution

[0042] B: acetonitrile

[0043] Elution gradient:

[0044] time (min) Mobile phase A (%) Mobile phase B (%) 0 90 10 5 90 10 10 30 70 13 30 70 15 90 10 20 90 10

[0045] Chromatographic column: Agilent Zorbax Eclipse XDB-phenyl (phenyl bonded column), 4.6*250mm, 5μm Detection wavelength: 220nm; flow rate: 1.0ml / min; column temperature: 30℃; injection volume: 10μl

[0046] Diluent: Water

[0047] Blank solution: water

[0048] Control stock solution: Weigh 24.4 mg of phenylglycine methyl ester hydrochloride reference substance and 23.6 mg of m-chlorophenylglycine methyl ester hydrochloride reference substance, put them into a 100ml volumetric flask, dissolve and dilute to the mark with diluent, and shake well. Then precisely pipette 5ml to 100ml volumetric flask, dissolve and dilute to the...

Embodiment 2

[0051] High Performance Liquid Chromatograph: Agilent 1260 Detector

[0052] Mobile phase: A: 0.1% phosphoric acid aqueous solution

[0053] B: methanol

[0054] Elution gradient:

[0055] time (min) Mobile phase A (%) Mobile phase B (%) 0 90 10 5 90 10 10 30 70 13 30 70 15 90 10 20 90 10

[0056] Chromatographic column: Agilent Zorbax Eclipse XDB-phenyl (phenyl bonded column), 4.6*250mm, 5μm Detection wavelength: 220nm; flow rate: 1.0ml / min; column temperature: 30℃; injection volume: 10μl

[0057] Diluent: Water

[0058]Blank solution: water

[0059] Control stock solution: Weigh 24.4 mg of phenylglycine methyl ester hydrochloride reference substance and 23.6 mg of m-chlorophenylglycine methyl ester hydrochloride reference substance, put them into a 100ml volumetric flask, dissolve and dilute to the mark with diluent, and shake well. Then precisely pipette 5ml to 100ml volumetric flask, dissolve and dilute to the mark...

Embodiment 3

[0062] High Performance Liquid Chromatograph: Agilent 1260 Detector

[0063] Mobile phase: A: 0.1% phosphoric acid aqueous solution

[0064] B: methanol

[0065] Elution gradient:

[0066] time (min) Phase A Phase B 0 80 20 5 80 20 14 20 80 15 20 80 15.1 80 20 20 80 20

[0067] Column: Agilent Zorbax Eclipse XDB-phenyl (phenyl bonded column), 4.6*250mm, 5μm

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Abstract

The invention discloses a method for analyzing 2-chlorophenylglycine methyl ester tartrate and impurities. The main impurities are phenylglycine methyl ester and m-chlorophenylglycine methyl ester. A high performance liquid chromatography method is adopted, an acid aqueous solution and an organic solvent are used as mobile phases, gradient elution is carried out on a sample solution of the chlorophenylglycine methyl ester, and the method is rapid, simple, accurate, good in repeatability and suitable for control and impurity research of the chlorophenylglycine methyl ester tartrate and impurities.

Description

technical field [0001] The invention belongs to the field of drug analysis, and more relates to an analysis method for measuring o-chlorophenylglycine methyl ester tartrate and impurities by HPLC. Background technique [0002] Clopidogrel bisulfate is a novel and highly effective anti-platelet aggregation drug. Developed by the French Sanofi Company in 1986, its bisulfate is clinically used, which is suitable for the treatment of atherosclerosis, acute coronary syndrome, and the prevention of restenosis and thrombotic complications after coronary stent implantation. Compared with other antiplatelet drugs, clopidogrel bisulfate has the advantages of good curative effect, low cost and few adverse reactions. In 1998, clopidogrel hydrogen sulfate was first listed in the United States, and then entered Europe, Canada, Australia, Singapore and other countries. The drug was launched in my country in 2001. It can inhibit ADP-induced platelet aggregation, and its strength and toler...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89
CPCG01N30/89
Inventor 董梦飞邓瑜李安排
Owner 苏州正济医药研究有限公司
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