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-Reference-Cited by-同舟云学术

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

Published:2023-07 Issue:6 Volume:19 Page:497-510
ISSN:1573-4129
Container-title:Current Pharmaceutical Analysis
language:en
Short-container-title:CPA

Author:

Shi Yunfeng¹,Lin Liqin²,Yao Qi³,Ren Xiaojuan³,Zhang Fengmei¹

Affiliation:

1. Department of Quality Assurance, Zhejiang Institute for Food and Drug Control, Key Laboratory for Core Technology of Generic Drug Evaluation National Medical Product Administration & Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province, Hangzhou, 310052, China

2. Department of Quality Assurance, Hangzhou Institute for Food and Drug Control, Hangzhou, 3100022, China

3. Department of Quality Assurance, Zhejiang University of Technology, Hangzhou, 310014, China

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.

Funder

Science and Technology project of the Zhejiang Food and Drug Administration

Publisher

Bentham Science Publishers Ltd.

Subject

Pharmaceutical Science,Molecular Medicine,Biochemistry,Biophysics

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