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Current Pharmaceutical Analysis

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ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

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Research Article

Development of a Suitable HPLC Method for the Analysis of Impurities in Clorprenaline and Bromhexine Capsules and Identification of Unknown Impurities by 2D LC-Q-TOF MS

Author(s): Yunfeng Shi*, Liqin Lin, Qi Yao, Xiaojuan Ren and Fengmei Zhang

Volume 19, Issue 6, 2023

Published on: 22 June, 2023

Page: [497 - 510] Pages: 14

DOI: 10.2174/1573412919666230601140557

Price: $65

Abstract

Background: Impurities may reduce antibacterial activity and affect clinical efficacy, However, there has been no report on the impurity of clorprenaline and bromhexine capsules.

Objective: In order to determine the impurities in compound clorprenaline and bromhexine capsules.

Methods: A new stability-indicating HPLC method was established. A Boston Green ODS column was used, and the UV detection was 225nm.

Results: The established method was highly specific, sensitive, accurate, and suitable for routine quality control of clorprenaline and bromhexine capsules. The structures of unknown impurities were characterized by the MS/MS data.

Conclusion: These results provide a sufficient basis for our subsequent study on the safety of Compound Clorprenaline and Bromhexine Capsules and also provide ideas for the impurity research of other compound preparations.

Keywords: Clorprenaline, bromhexine capsules, impurity, HPLC, validation, 2d lc-q-tof ms.

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Graphical Abstract

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