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

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.