Objective: To establish an HPLC method for simultaneous determination of the 11 related substances in pitavastatin calcium. Methods: ODS-3 C18 column (250 mm×4.6 mm, 5 μm) was adopted. The mobile phase A was composed of acetic acid-sodium acetate buffer (0.6 mL glacial acetic acid was added to 1 000 mL purified water, and pH was adjusted to 2.5 with 0.1% sodium acetate solution). And the mobile phase B was acetonitrile. The gradient elution was performed. The flow rate was 1.0 mL·min-1.The detection wavelength was 245 nm and the column temperature was 30 ℃. Results: Pitavastatin calcium and its related substances were separated well, the detection limits of pitavastatin calcium and impurities were all below 0.01 μg·mL-1. The RSD of the recoveries of relevant substances in precision tests were less than 6%. The recovery rates were between 95.5% and 110.2% and the RSD of each recovery rate was less than 5%. After the sample solution was placed at room temperature for 48 h, all impurities except impurity A were stable. Therefore, changing the column temperature, flow rate, and replacing the chromatographic column had no effect on the detection results of related substances. Conclusion: The established method is simple, sensitive and accurate, which can be used to determinate the related substances of pitavastatin calcium and to control the quality of pitavastatin calcium.
KANG Le, LIN Meng, MENG Fan-ling, LIU Yin
. Determination of related substances of pitavastatin calcium by high performance liquid chromatography[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(10)
: 1812
-1822
.
DOI: 10.16155/j.0254-1793.2021.10.19
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