Development and application of reference materials containing mixed degradation products of amoxicillin and ampicillin.
- Author:
Wei LI
;
Wei-Qing ZHANG
;
Xiang LI
;
Chang-Qin HU
- Publication Type:Journal Article
- MeSH:
Amoxicillin;
chemistry;
Ampicillin;
chemistry;
China;
Chromatography, High Pressure Liquid;
Drug Contamination;
Mass Spectrometry;
Reference Standards
- From:
Acta Pharmaceutica Sinica
2014;49(9):1310-1314
- CountryChina
- Language:Chinese
-
Abstract:
Reference materials containing mixed degradation products of amoxicillin and ampicillin were developed after optimization of preparation processes. The target impurities were obtained by controlled stress testing, and each major component was identified with HPLC-MS and compared with single traceable reference standard each. The developed reference materials were applied to system suitability test for verifying HPLC system performed in accordance with set forth in China Pharmacopeia and identification of major impurities in samples based on retention and spectra information, which have advantages over the methods put forth in foreign pharmacopoeias. The development and application of the reference materials offer an effective way for rapid identification of impurities in chromatograms, and provide references for analyzing source of impurities and evaluation of drug quality.
