高效液相色谱法测定萘哌地尔制剂的含量

Determination of naftopidil preparation by HP LC method

摘要: 目的:建立高效液相色谱法测定萘哌地尔制剂含量的分析方法。方法:采用Waters C18色谱柱(150. 0 mm4. 6 mm, 5m), 流动相为乙腈-甲醇-0. 02 mol/L乙酸钠缓冲液(40∶30∶30), 流速为1 ml/min, 检测波长为283 nm, 柱温为30℃, 进样量为10l。结果:萘哌地尔在0. 998～29. 940g/ml具有良好的线性关系(r=0. 999 9);高、中、低3个浓度的平均回收率分别为101. 61%、100. 44%和99. 28%, RSD(%)分别为0. 25、0. 12和0. 44。结论:高效液相色谱法简便准确, 重复性好, 适用于萘哌地尔制剂的质量控制。

Abstract: Objective: To establish an HP LC method for determination of naftopidil preparations. Methods: In this study, Waters C18 column(150. 0 mm 4. 6 mm, 5 m) was used, with acetonitrile-methanol-0. 02 mol/L sodium acetate(40∶ 30∶ 30) as mobile phase at a flow rate of 1. 0 ml/min, and the detection wavelength was 283 nm. The injection volume was 10 l and column temperature was set at 30 ℃. Results: The calibration curve was over the range of 0. 998-29. 940 g/ml(with the correlation coefficient of 0. 9999) . The mean recovery of three concentration were 101. 61%, 100. 44% and 99. 28% while the RSD(%) was 0. 25, 0. 12 and 0. 44, respectively. Conclusions: The method is simple, accurate, reproducible and suitable for the quality control of Naftopidil preparations.