OBJECTIVE To establish a RP-HPLC method for determination of simvastatin and its related substance lovastatin. METHODS The chromatographic conditions were: a Waters Symmetry C18 column (250 mm×4.6 mm, 5 μm), a mixture of acetonitrile-sodium dihydrogen phosphate (pH 5.4) (65∶35) as mobile phase, flow rate 1.0 mL·min-1, and detected at 238 nm. RESULTS The linear ranges of lovastatin and simvastatin were 0.3～3.0 μg·mL-1,0.03～0.30 mg·mL-1, respectively. The average recovery were 100.2% (RSD=1.5%) and 99.4% (RSD=1.7%), respectively. CONCLUSION The method is simple, quick, sensitive, accurate, and reproducible. It can be used to the quality control of synthetic simvastatin products.
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