西咪替丁有关物质检查方法的再评价

Revaluation of the Determination Method for Related Substances in Cimetidine

关键词:  西咪替丁  有关物质  TLC  HPLC

Key words:  cimetidine  related substances  TLC  HPLC

摘要:

目的 对西咪替丁有关物质测定方法进行评价。方法 分别用中国药典2005年版的TLC和自建立的HPLC，对西咪替丁有关物质进行测定。选用C18柱，以甲醇-水(240∶760)(每1 000 mL甲醇水溶液中含磷酸0.3 mL及正已烷磺酸钠0.94 g)为流动相，检测波长为220 nm。结果 TLC检测7个厂家共8批西咪替丁的有关物质均符合标准规定(0.5%)；HPLC检测结果显示仅1个厂家1批西咪替丁的有关物质在0.5%之内，其他批次样品均超出0.5%。结论 TLC法无法准确客观检测出本品的有关物质，HPLC测定结果更准确可靠。

Abstract:

OBJECTIVE To revalue the determination method for related substances in cimetidine. METHODS The related substances in cimetidine were tested by TLC and HPLC, respectively. The HPLC method was carried out on a C18 column with the mixture of methanol-water(240∶760) (dissolved 0.3 mL of phosphoric acid and 0.94 g sodium hexanesulfonate in 1 000 mL methanol) as mobile phase and UV wavelength at 220 nm. RESULTS The results of related substances tested by TLC were all within 0.5% in 8 batches of cimetidine from 7 manufacturers, but only one batch was within 0.5% by HPLC. CONCLUSION The result of related substances in cimetidine tested by HPLC was more credible than the result tested by TLC.