Chromatographic fingerprint and quality consistency of colistimethate sodium
10.11665/j.issn.1000-5048.2023071903
- VernacularTitle:多黏菌素E甲磺酸钠的色谱指纹图谱与质量一致性研究
- Author:
Xuan LI
1
;
Minwen HUANG
;
Jie ZHOU
;
Yaozuo YUAN
;
Taijun HANG
Author Information
1. 江苏省食品药品监督检验研究院
- Publication Type:Journal Article
- Keywords:
colistimethate sodium;
fingerprint;
similarity evaluation;
multi-component content determination;
quality evaluation method
- From:
Journal of China Pharmaceutical University
2023;54(6):749-756
- CountryChina
- Language:Chinese
-
Abstract:
The UPLC fingerprint of colistimethate sodium was established for the study of quality consistency.The chromatographic column was Acquity UPLC? Peptide CSH C18 (2.1 mm × 150 mm, 1.7 μm).The mobile phase A was phosphate buffer-acetonitrile (19∶1), and the mobile phase B was phosphate buffer-acetonitrile (1∶1).The mobile phase was in gradient elution at a flow rate of 0.3 mL/min.The column temperature was set at 30 °C and the detection wavelength was 210 nm.The similarity of the fingerprints was analyzed with the Similarity Evaluation System for Chromatographic Fingerprint of Tradition Chinese Medicine (Version 2012) in combination with content determination of multiple index components to evaluate the quality consistency of imported and domestic bulk drugs.The result showed that both the original and generic bulk drugs met the specified limit requirements in the European Pharmacopoeia standards, and that their UPLC fingerprints were highly similar, indicating that the quality of the two substances was consistent.Establishing a fingerprint for similarity evaluation and combining it with the results of indicator component content determination as a comprehensive evaluation method for the study of drug quality consistency of complex components has the characteristics of fast, accurate, and comprehensive, which is helpful for drug quality evaluation and provides ideas for the evaluation of antibiotic quality consistency of complex components.
