Analysis of related substances in bromhexine hydrochloride tablets / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate the status of related substances in bromhexine hydrochloride tablets and to find the existing problems. METHODS: 95 batches of samples from six domestic manufacturers were tested using statutory methods combined with exploratory research, and the results were evaluated by statistical analysis. RESULTS: The related substances in 95 batches of bromhexine hydrochloride tablets met the requirement of current specification. The total amount was not more than 0.4%. The exploratory studies on domestic tablets, raw materials and tablets produced by original manufacturer revealed that 12 impurities were detected in the samples from six domestic manufacturers, which originated mainly from the raw material. The species and contents of the impurities in domestic samples were different with those in the product of original manufacturer. The structure of the unknown impurity with the highest content was identified by LC-MS/MS, and it was judged to be produced in the manufacturing process of the raw material. CONCLUSION: The related substances in domestic bromhexine hydrochloride tablets are in good control overall and have met the requirement of current statutory specification. The impurities originate mainly from the raw material, so improving the quality of the materials at the source is the critical factor for promoting the quality level of bromhexine hydrochloride tablets.