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目的为流通池法测定体外释放度提供含量测试的方法验证。方法使用含0.2%的吐温20的PBS(PH=7.4)溶液作为介质剂,雷帕霉素在该介质剂中的含量测试的方法学验证。结果准确度、专属性、线性和范围、精密度、检测限和定量限均可满足中国药典要求,且在(37±2)℃时的稳定性较好。结论雷帕霉素含量测定可以采用含0.2%的吐温20的PBS(PH=7.4)溶液作为介质,进行流通池法体外释放度的测试。
Objective To provide a method for the determination of in vitro release by the flow cell method. Methods Methodological validation of content testing of rapamycin in this media using a solution of 0.2% Tween 20 in PBS (pH = 7.4) as the vehicle. The results of accuracy, specificity, linearity and range, precision, detection limit and limit of quantification can meet the requirements of the Chinese Pharmacopoeia, and the stability at (37 ± 2) ℃ is better. Conclusion Determination of rapamycin content can be 0.2% Tween 20 containing PBS (PH = 7.4) solution as a medium, the flow cell pool in vitro release test.