目的 建立鹽酸曲美他嗪緩釋片中有關(guān)物質(zhì)的高效液相色譜測(cè)定方法.方法 采用Diamonsil C₁₈色譜柱(30 ℃,檢測(cè)波長(zhǎng)為210 nm,進(jìn)樣量：20 μL.結(jié)果 在所選定的液相色譜條件下,有關(guān)物質(zhì)與主藥分離良好.鹽酸曲美他嗪、雜質(zhì)A、雜質(zhì)B和雜質(zhì)C的檢出限分別為10.2、4.4、4.5、8.0 ng.結(jié)論 該方法操作簡(jiǎn)單,重復(fù)性好,專屬性強(qiáng),可用于控制鹽酸曲美他嗪緩釋片中的有關(guān)物質(zhì).

Objective To establish an RP-HPLC method for the determination of related substances in Trimetazidine Dihydrochloride Modified Release Tablets. Methods The separation was performed on a Diamonsil C₁₈ column (30 ℃, and the detection wavelength was set at 210 nm. Results Trimetazidine dihydrochloride and its related substances could be completely separated under the conditions. The detection limits of trimetazidine dihydrochloride, impurities A, B, and C were 10.2, 4.4, 4.5, and 8 ng. Conclusion The method is simple, quick, accurate, and reliable, which can control the related substances in Trimetazidine Dihydrochloride Modified Release Tablets.