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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1000mL甲醇水溶液中含磷酸0.3mL及正已烷磺酸钠0.94g)为流动相,检测波长为220nm。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。
Objective To evaluate the method of substance determination of cimetidine. Methods The Chinese Pharmacopoeia 2005 edition of TLC and self-established HPLC, cimetidine related substances were determined. A C18 column was used with a mobile phase of methanol-water (240: 760) containing 0.3 mL of phosphoric acid and 0.94 g of sodium n-alkanesulfonate per 1000 mL of methanol aqueous solution. The detection wavelength was 220 nm. Results TLC detected 7 batches of 8 batches of cimetidine related substances were in line with the standard (0.5%); HPLC test results showed that only 1 manufacturer of a batch of cimetidine related substances within 0.5% of the other batches Sub-samples are more than 0.5%. Conclusion TLC method can not accurately and objectively detect the related substances of this product, and the HPLC determination results are more accurate and reliable.