硫酸茚地那韦胶囊溶出度检查方法考察及改进

目的考察并改进硫酸茚地那韦胶囊国内现行质量标准溶出度检查方法。方法通过比较4个现行质量标准溶出度检查方法,提出改进方法,新方法采用桨法,转速50转/min,以水900 mL为溶出介质,用HPLC法测定,采用SHISEIDO C8柱(250 mm×4.6 mm,5μm),以乙腈-0.005 mol/L磷酸二氢钾溶液-0.005 mol/L磷酸氢二钾溶液(50:25:25)为流动相,检测波长260nm。结果与结论同批样品,UV法的测定结果明显高于HPLC法;所建方法可用于检查硫酸茚地那韦胶囊的溶出度。

Improvement and Inspection of Determination Method of Dissolution for Indinavir Sulfate Capsules

Objective To inspect and improve the dissolution determination methods of indinavir sulfate capsules in current internal quality standard.Methods Through comparing the difference among the four dissolution determination methods,the new method for dissolution determination was established,which was the paddle method.Water of 900 mL was used as the dissolution medium,the rotation speed was 50 r/min and HPLC method was used for the detection.The HPLC column was SHISEIDO C8 column(250 mm×4.6mm,5 μm),the mobile phase was acetonitrile-0.005mol/L potassium dihydrogen phosphate solution-0.005mol/L dipotassium hydrogen phosphate solution(50:25:25) and the UV detection wavelength was 260 nm.Results and Conclusion For the same batch sample,the results from UV method were obviously higher than HPLC method.This method can be used to determine the dissolution of indinavir sulfate capsules.