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[摘要]
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(200 mm×4.6 mm,5 μm),流动相为醋酸铵缓冲溶液(pH 6.0)-乙腈-甲醇(80∶15∶5),检测波长为280 nm,体积流量为1.0 mL/min,柱温为25℃,进样量为20 μL。结果 米诺环素在0.05~1 mg/mL线性关系良好(r=0.999 7),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。
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[Abstract]
Objective To establish an HPLC method for the determination of minocycline 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, 5 μm) 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.
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