Chromatographic fingerprint and quality consistency of colistimethate sodium

LI Xuan; HUANG Minwen; ZHOU Jie; YUAN Yaozuo; HANG Taijun

doi:10.11665/j.issn.1000-5048.2023071903

Journal of China Pharmaceutical University > 2023 > 54(6): 749-756. > DOI: 10.11665/j.issn.1000-5048.2023071903

LI Xuan, HUANG Minwen, ZHOU Jie, YUAN Yaozuo, HANG Taijun. Chromatographic fingerprint and quality consistency of colistimethate sodium[J]. Journal of China Pharmaceutical University, 2023, 54(6): 749-756. DOI: 10.11665/j.issn.1000-5048.2023071903

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Chromatographic fingerprint and quality consistency of colistimethate sodium

1.
Jiangsu Institute for Food and Drug Control, Nanjing 210019
2.
NMPA Key Laboratory for Impurity Profile of Chemical Drugs,Nanjing 210019
3.
Department of Pharmaceutical Analysis, China Pharmaceutical University,Nanjing 210009
4.
Chia Tai Tianqing Pharmaceutical Group Co Ltd, Lianyungang 222062, China

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Received Date: July 18, 2023
Revised Date: December 10, 2023

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Abstract

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.
- colistimethate sodium,
- fingerprint,
- similarity evaluation,
- multi-component content determination,
- quality evaluation method

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