高效液相色谱法测定硫酸阿扎那韦胶囊中主药的含量

HPLC determination of atazanavir sulfate in atazanavir sulfate capsules

目的建立高效液相色谱法测定硫酸阿扎那韦胶囊中硫酸阿扎那韦含量的方法。方法色谱柱为KromasilC18(250 mm×4.6 mm,5μm),流动相为0.02 mol L-1醋酸铵缓冲液-甲醇(25:75),流速为1.0 mL min-1,紫外检测波长为250 nm,进样量为20μL。结果硫酸阿扎那韦检测浓度在20.27～182.4μg mL-1线性关系良好(r=0.999 9);平均回收率为99.5%(RSD=0.53%)。结论本方法操作简便、快捷,结果准确、可靠,可用于硫酸阿扎那韦胶囊的主药含量控制。

Objective To establish an HPLC method for the determination of atazanavir sulfate in atazanavir sulfate capsules.Methods Chromatographic column Kromasil C18（250 mm×4.6 mm,5 μm） was used.The mobile phase was 0.02 mol ？ L-1 acetate buffer-methanol（25 ： 75） with flow rate at 1.0 mL ？ min-1.The detection wavelength was 250 nm and the sample size was 20 μL.Results The calibration curve of atazanavir sulfate showed a good linearity at 20.27-182.4 μg ？ mL-1（r=0.999 9）,and the average recovery of atazanavir sulfate was 99.5%,RSD=0.53%.Conclusion This method is rapid,accurate and reliable,and it is applicable for the determination of atazanavir sulfate in atazanavir sulfate capsules.