HPLC法测定盐酸米诺环素缓释微丸胶囊中的米诺环素和有关物质

Determination of minocycline hydrochloride and its related substances in sustained-release pellets capsules by HPLC

目的建立反相HPLC法测定盐酸米诺环素缓释微丸胶囊中米诺环素的量和有关物质。方法 Diamonsil C18柱(200mm×4.6mm,5μm),流动相为醋酸铵缓冲溶液(pH6.0)-乙腈-甲醇(80:15:5),检测波长为280nm,体积流量为1.0mL/min,柱温为25℃,进样量为20μL。结果米诺环素在0.05～1mg/mL线性关系良好(r=0.9997),方法精密度RSD为0.6%,平均回收率为99.46%,RSD为0.8%,各杂质峰与主峰分离良好。结论该方法简便,专属性强,准确可靠,可用于测定盐酸米诺环素缓释微丸胶囊中的米诺环素及有关物质。

Objective To establish an HPLC method for the determination ofminocycline hydrochloride and its related substances in minocycline hydrochloride sustained-release pellets capsules. Methods HPLC was performed on a Diamonsil C18 column （200 mm×4.6 mm, 5μm） using ammonium acetate （pH 6.0）-acetonitrile-methanol （80：15：5） as the mobile phase at a flow rate of 1.0 mL/min. The detection wavelength was 280 nm and the column temperature was 25℃. Results The linear range of minocycline was 0.05-1 mg/mL （r = 0.999 7）, precision RSD = 0.6%, and the average recovery was 99.46% （RSD = 0.8%）. Conclusion The established method is simple, accurate, and specific, and could be used for the quality control of minocycline hydrochloride sustained-release pellets capsules.