超高效液相色谱法测定注射用甲泼尼龙琥珀酸钠含量的不确定度评定

Uncertainty Assessment for the Assay Determination of Methylprednisolone Sodium Succinate for Injection by UPLC

目的建立超高效液相色谱(UPLC)法测定注射用甲泼尼龙琥珀酸钠含量的不确定度评价方法。方法采用UPLC测定注射用甲泼尼龙琥珀酸钠含量,根据检验过程,分析影响不确定度因素的来源,对各个不确定度因素进行评定,得出扩展不确定度,对含量测定结果进行风险评估。结果本试验合成标准不确定度为0.36%,扩展不确定度为0.7%,含量测定结果报告为(100.2±0.7)%,k=2。结论该方法适用于UPLC内标法测定注射用甲泼尼龙琥珀酸钠含量的不确定度。

OBJECTIVE To evaluate the measurement uncertainty for the assay determination of methylprednisolone sodium succinate for injection by UPLC.METHODS UPLC was established to determinate the content of methylprednisolone sodium succinate for injection.According to the inspection process,the variable parameters affect uncertainty were analyzed,the combined uncertainty and extended uncertainty were obtained.RESULTS The combined uncertainty was 0.36%,the expanded measurement uncertainty was 0.7%,and the assay of methylprednisolone sodium succinate for injection was(100.2±0.7)%,k=2.CONCLUSION The method is suitable for the uncertainty measurement evaluation of the content determination of methylprednisolone sodium succinate for injection.