HPLC法测定克霉唑阴道片含量的方法研究

Study on determination of Clotrimazole Vaginal Tablets by HPLC

目的建立克霉唑阴道片含量的高效液相色谱测定方法。方法采用大连依利C18色谱柱,流动相为甲醇-磷酸缓冲液（取磷酸5 m L,加50%甲醇溶液稀释至1 000 m L,用三乙胺调节p H值至3.8）（40∶60）,流速：1.0m L·min-1,检测波长230 nm,进样量为10μL。结果在该色谱条件下,克霉唑在浓度为0.025~0.2 mg·m L-1范围内线性关系良好,回归方程为：A=30 397C-3.353 83,r=0.999 9,重复性试验RSD为1.35%,平均回收率为96.67%（RSD=1.33%）。结论本法灵敏、简便、准确、重复性好,能有效控制克霉唑阴道片的含量。

Objective To establish an HPLC method for the determination of Clotrimazole Vaginal Tablets. Methods Dalian C18 chromatographic column was adopted with methanol- phosphate buffer（ phosphate from 5 m L and 50% methanol solution was diluted to 1 000 m L,with three procedures for adjusting the p H value to 3. 8）（ 40∶60） as mobile phase,and the flow rate was 1. 0 m L·min- 1,the detection wavelength was 230 nm,the injection volume was 10 μL. Results Under the chromatographic conditions,the linear range of clotrimazole was 0. 025 ~ 0. 2 mg·m L- 1,the regression equation was A =30 397C- 3. 353 83,r = 0. 999 9. The RSD of repeatability test was 1. 35%,the average recovery rate was 96. 67%（ RSD =1. 33%）. Conclusion This method was sensitive,simple,accurate,reproducible,and can effectively control the content of Clotrimazole Vaginal Tablets.