高效液相色谱法测定螺内酯的有关物质

目的:建立HPLC测定螺内酯有关物质的方法。方法:采用Venusil XBP-C8柱(4.6 mm×250 mm,5μm),以乙腈-四氢呋喃-水(6∶19∶75)为流动相,流速为1.0 mL.min-1,检测波长为254 nm和283 nm。结果:螺内酯在1.003 6~100.36 mg.L-1(杂质限度在0.1%~10.0%)、坎利酮在1.014 4~101.44 mg.L-1(杂质限度在0.1%~10.0%)的浓度范围内线性关系良好,r=0.999 9(n=6),坎利酮和螺内酯的最低检出限分别为0.01%和0.01%。结论:本法操作简单、快速、准确,可用于螺内酯中有关物质的测定。

Determination of Related Substances in Spironolactone by HPLC

Objective： To establish an HPLC method for the determination of related substances in Spironolactone. Method： Venusil XBP-C8 column（4. 6 mm × 250 mm ,5μm） was used, the mobile phase was Acetonitrile-Tetrahydrofuran-Water （6： 19：75 ）. The flow rate was 1.0 mL ·min^-1 and detection wavelength was 254 nm and 283 nm, the column temperature was 40℃. Result： The standard curve of spironolactone was linear over the concentration range of 1. 003 6 ~ 100. 36 mg~ L- ~ （ the related substances limit was 0. 1% - 10. 0% ）. The standard curve of Canrenoner was linear over the concentration range of 1. 014 4 - 101.44 mg·L^-1 （the related substances limit was 0. 1% - 10. 0% ）, r =0. 999 9（n =6）. The limit of detection of Canrenoner and Spironolaetone were 0. 01% and 0. 01%. Conclusion： The method is simple, rapid and accurate, and can he used for determining the related substances in Spi- ronolactone.