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

被引：0
|
作者：
Shi, Yunfeng [1 ,2 ]
Lin, Liqin [3 ]
Yao, Qi [4 ]
Ren, Xiaojuan [4 ]
Zhang, Fengmei [1 ,2 ]
机构：
[1] Zhejiang Inst Food & Drug Control, Dept Qual Assurance, Key Lab Core Technol Gener Drug Evaluat Natl Med P, Hangzhou 310052, Peoples R China
[2] Key Lab Drug Contacting Mat Qual Control Zhejiang, Hangzhou 310052, Peoples R China
[3] Hangzhou Inst Food & Drug Control, Dept Qual Assurance, Hangzhou 310006, Peoples R China
[4] Zhejiang Univ Technol, Dept Qual Assurance, Hangzhou 310014, Peoples R China
来源：
CURRENT PHARMACEUTICAL ANALYSIS | 2023年 / 19卷 / 06期
关键词：
Clorprenaline; bromhexine capsules; impurity; HPLC; validation; 2d lc-q-tof ms;
D O I：
10.2174/1573412919666230601140557
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
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.
引用
收藏
页码：497 / 510
页数：14
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