阿法骨化醇软胶囊溶出度检测方法的建立

Dissolution determination of alfacalcidol soft capsules

目的:建立阿法骨化醇软胶囊溶出度检测方法。方法:采用高效液相色谱(HPLC)法,色谱柱为Kromasil 100-5 C18(150 mm×4.6 mm),流动相为水-乙腈-甲醇,梯度洗脱方式,进样量为300μL,检测波长为265 nm。结果:方法在0.25~7 ng·mL^-1范围内有良好的线性(r2> 0.99),0.25μg规格样品平均回收率为101.66%(n=9),0.5μg规格样品平均回收率为98.73%(n=9)。结论:经方法学验证建立的高效液相色谱法简便、准确、灵敏度高。

Objective: To establish a dissolution determination method of alfacalcidol soft capsules.Methods:HPLC was performed on a column of Kromasil 100-5 C18(150 mm ×4.6 mm) with the mobile phase water-acetonitrilemethanol in a gradient elution. The injected volume was set at 300 μL and the wavelength 265 nm.Results: The method shows a good linear range of 0.25 ~7 ng·mL^-1(r2> 0. 99). The average recovery was 101 66%(n= 9)and 98.73%(n= 9) of 0. 25 μg or 0. 5 μg per grain, respectively.Conclusion: A simple and sensitive HPLC method has been developed and validated for dissolution determination of alfacalcidol soft capsules.