Determination of high molecular weight impurities in Cephradine Capsule by gel filtration chromatography

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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2006, Vol. 11 ›› Issue (3): 339-341.

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Determination of high molecular weight impurities in Cephradine Capsule by gel filtration chromatography

HUANG Hai-yan, FAN Jing

Nanjing Chang'ao Pharmaceutical Science and Technology Limited Company,Nanjing 210022,Jiangsu,China

Received:2006-01-19 Revised:2006-01-19 Online:2006-03-26 Published:2020-12-04

Abstract

Abstract: AIM: To develoPa method for the determination of high molecular weight impurities in Cephradine Capsule.METHODS: Gel filtration chromatography was adopted.The analytical column was Sephadex G-10 gel column.The mobile phase was consisted of A,0.2mol·L^-1 phosphate buffer (pH 8.0) and B,water.The flow rate was 1.0 ml·min^-1.The detection wavelength was at UV 254 nm.RESULTS: The content of high molecular weight impurities in Cephradine Capsule is less than 0.5%.CONCLUSION: The method is sensitive,accurate,simple and convenient enough to be used for the quality control of Cephradine Capsule.

Key words: gel filtration chromatography, Cephradine Capsule, high molecular weight impurity

CLC Number:

R969.1

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Determination of high molecular weight impurities in Cephradine Capsule by gel filtration chromatography

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