校正因子法同时测定非洛地平及其片剂中的3个杂质

目的：建立校正因子法同时测定非洛地平及其片剂中3个杂质的含量。方法：采用高效液相色谱法，以非洛地平为参照物质，分别计算3个杂质（杂质A、B、C）的相对保留时间及相对校正因子，并对测定方法的耐用性进行考察；用相对校正因子计算非洛地平及其片剂中相应杂质的含量，同时与杂质对照品法测定的结果进行比较，以验证方法的准确性。结果：3个杂质相对于主成分非洛地平的相对保留时间分别为0.84、0.75、1.35，相对校正因子分别为1.96、0.96和1.06；方法学验证试验表明所建立的方法符合定量测定杂质含量的要求；校正因子法的计算值与对照品法测定的结果无显著性差异。结论：本法能够准确测定非洛地平及其片剂中杂质A、B、C的含量。

Objective: To establish an HPLC method with the relative correction factors for simultaneous quantification of three impurities (A,B and C) in felodipine and its tablets. Methods: The relative retention times and the relative correction factors of three impurities were determined respectively by HPLC using felodipine as the internal standard,and the robustness of the method was verified.The results obtained by the proposed method were compared with those by using the impurities' reference standards to verify the method accuracy. Results: To felodipine,the relative retention times of three impurities were 0.84,0.75 and 1.35,and their relative correction factors were 1.96,0.96 and 1.06,respectively.The validation test showed that the proposed method met the requirements for the intended analytical applications.There was no significant difference between the results by relative correction factors and by the reference standards. Conclusion: The method with relative correction factors can be applied to determine the impurities in felodipine and its tablets.

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