TESTING METHOD FOR POTENTIAL MUTAGENIC IMPURITIES IN PITAVASTATIN CALCIUM TABLET

摘要

A testing method for potential mutagenic impurities in a pitavastatin calcium tablet. After a solvent is used to dissolve a sample to be tested, high performance liquid chromatography is utilized to perform testing, where chromatography conditions are as follows: mobile phase: an organic acid salt buffer solution and acetonitrile; flow rate: 1.0mL / min; column temperature: 25-40 ℃; chromatography column: octadecyl silane bonded silica is used as a filler; injection volume: 50 μL; testing wavelength: 270-280 nm; elution mode: gradient elution; and the potential mutagenic impurities are impurity 1 and impurity 2. The present method can achieve effective separation of pitavastatin calcium, impurity 1, and impurity 2; said method can also prevent another related impurity of pitavastatin calcium from interfering with testing for impurity 1 and impurity 2, and can accurately measure the potential mutagenic impurity 1 and impurity 2 contents in a pitavastatin calcium tablet, effectively monitoring pitavastatin calcium tablet pharmaceutical quality, and increasing medication safety.