HPLC法测定司坦唑醇分散片含量的方法学研究

目的:建立HPLC对司坦唑醇分散片的含量测定方法,并进行方法学考察。方法:采用高效液相色谱法。色谱柱为大连依利特YWG C18(10μm,4.6mm×250mm);流动相为0.05mol/L磷酸二氢铵溶液-甲醇(25∶75);流速为1mL/min;柱温为25℃;检测波长为230nm。结果:司坦唑醇在19.08～228.96μg/mL范围内峰面积呈良好的线性关系(r=0.9999)。总回收率为99.54%(n=9),RSD(n=9)为0.99%。结论:所建立的方法简便可行,重复性好,能有效控制司坦唑醇分散片的质量。

Study on the Content of Stanozolol in Stanozolol Dispersible Tablets by HPLC

Objective：To establish the HPLC method for determining the content of stanozolol in stanozolol dispersible tablets and evaluate the methodology. Methods：Using a HPLC method with the chromatography column of which was hypersil YWG C18 （10um, 4.6×250mm）, the mobile phase was consisted of ammonium dihydrogen phosphate solution （0.05mol/L） and methanol （25 ： 75,V/V）, flow rate was 1mL/min, column temperature was 25 ℃, and the detection wavelength was 230nm. Results ： There was a good linearity within the range of 19.08 to 228.96tLg/mL of stanozolol （R=0. 9999）. The average recovery was 99.54% （n= 5）. The RSD was 0.99 % （n= 5）. Conclusion;The identification method was simple and feasible. It had good reproducibility and could control the quality of stanozolol dispersible tablets.