盐酸马普替林有关物质检查商榷

Discussion on test of related substances of maprotiline hydrochloride

目的:对《中国药典》2020年版二部盐酸马普替林有关物质的检查方法提出意见和建议。方法:根据《中国药典》2020年版方法(TLC法)对可能出现的检验结果进行分析,存在结论无法判定的情况。为此建立了HPLC法作为有关物质检查的方法。结果:HPLC法通过计算杂质峰面积,结论能明确判定。结论:HPLC法解决了结论无法判定的情况,更具可操作性。

Objective:To discuss the test methods of related substances of maprotiline hydrochloride in the Chinese Pharmacopoeia 2020.Methods:The possible test results were analyzed according to the TCL method in the Chinese Pharmacopoeia 2020,and there was the situation that the results can′t be judged.So HPLC method was established for the test of related substances of maprotiline hydrochloride.Results:The impurity peak area was used for calculation for HPLC method,and the conclusion could be made clearly.Conclusion:The HPLC method solves the situation that the conclusion can′t be made,and it is more practicable.