高效液相色谱法测定盐酸氯米帕明片中氯米帕明的含量及有关物质

目的采用HPLC法测定盐酸氯米帕明片中氯米帕明的含量及有关物质。方法采用色谱柱：十八烷基硅烷键合硅胶柱（Venusil XBP C18,4.6 mm×150 mm,5μm） 流动相：1.25%庚烷磺酸钠溶液-1.0%三氯醋酸溶液-2.5%磷酸二氢钾溶液-甲醇（80∶50∶40∶330） 检测波长：251 nm 流速：1.0 mL.min-1 进样量：10μL 柱温：40℃。结果在该色谱条件下,盐酸氯米帕明片在65.52~152.88μg.mL-1具有良好的线性关系（r=0.9998） 平均回收率为99.85%,RSD为0.19%。结论本法简便、快速、准确,专属性好。为中国药典2010年版盐酸氯米帕明片含量、含量均匀度和有关物质的修订提供了依据。

Determination of clomipramine hydrochloride tablets and related substances by HPLC

Objective To establish an HPLC method for the content determination of clomipramine hydrochloride tab- lets and related substances. Methods The separation was performed on Venusil XBP C18 （4. 6 mm× 150 mm, 5 μn）. The mobile phase was composed of 1.25% heptane-l-sulfonic sodium salt solution-diethylamine-1.0M triehloroaeetieacid solution-diethylamine-2.5 % potassium dihydrogen phosphate solution-diethylamine methanol （80 ： 50 ： 40 ： aao）. The flow rate was 1.0 mL ·min-1, the detective wavelength was 251 nm, and the colunn temperature was 40 ℃. Results The linear range of clomipramine hydrocluoride was 65.52-152. 88 μg · mL-1X （r=0. 999 8） . The average recovery was 99.85%, and the RSD was 0.19%. Conclusion The method is simple, quick and accurate, and is suitable for the determination of clomipramine hydrocluoride and its related substances. It provides reference for China Pharmacopoeia （2010） to set up the standard for the content determination, content uniformity, and related substances of clomipramine hydrochloride tablets.