HPLC法测定米诺地尔片的含量及含量均匀度

Determination of Content and Content Uniformity of Minoxidil Tablets by HPLC

目的:建立高效液相色谱法测定米诺地尔片的含量及含量均匀度。方法:采用XBridge C18(250 mm×4.6 mm,5μm)色谱柱,流动相为甲醇-0.03 mol·L^-1磷酸二氢钾溶液-三乙胺(60∶40∶0.1)(用磷酸调节p H至3.5),流速为1.0 ml·min^-1,检测波长为287 nm,柱温为30℃,进样量:10μl。结果:米诺地尔在8.056~32.224μg·ml-1(r=0.999 9)范围内线性关系良好;平均回收率为99.68%(RSD=0.36%,n=9),3批样品的平均含量分别为100.2%,100.5%,99.8%,含量均匀度分别为5.5,6.2,4.9。结论:所用方法简便准确,重复性好,可用于控制米诺地尔片的质量。

Objective： To establish an HPLC method for the determination of content and content uniformity of minoxidil tablets. Methods： An Xbfidge Cls column （250 mm x 4.6 mm, 5 μm）was used with methanol-0.03 mol · L-1 KH2PO4 solution -triethyl- amine（60： 40：0.1 ） （adjusting pH to 3.5 with phosphoric acid ） as the mobile phase. The flow rate was 1.0 ml · min-1 and the detection wavelength was 287 nm. The column temperature was 30℃ and the injection volume was 10μl. Results： There was a good linear relationship within the range of 8. 056-32.224 μg· ml - l （ r = 0.999 9 ）. The average recovery was 99.68% （RSD = 0.36%, n = 9 ）. The average content of 3 batches of samples was 100.2% ,100.5% and 99.8% and the content uniformity was 5.5,6.2 and 4.9, respectively. Conclusion ： The method is simple and accurate with good reproducibility, which can be used in the quality control of mi- noxidil tablets.