Development and Validation of a High Performance Liquid Chromatographic Method for Simultaneous Determination of Ten Process-related Impurities of Clevidipine Butyrate

A reversed phase high performance liquid chromatographic (RP-HPLC) method coupled with DAD was developed for the simultaneous determination of ten process. related impurities (PRI) of Clevidipin Butyrate (CLE). The chromatographic separation was carried out on a Waters symmetry C-18 column (250 mm x 4.6 mm, 5 mu m) and all components were monitored at 220 nm. The mobile phase consisted of 0.05 mol/L sodium dihydrogen phosphate with pH 2.5 adjusted by phosphoric acid (MPA) and a mixed solution of acetonitrile and methanol (3.2, V/V). Flow rate was kept at 1.5 mL/min, the injection volume was 20 mu L for all injections, and the column temperature maintained at 35 degrees C. The method was further validated with respect to selectivity, linearity, limit of detection (LOD), limit of quantitation (LOQ), precision and accuracy. A good linearity was obtained in the measured concentration ranges for CLE and ten impurities (r >= 0.9970), and the detection limits were 0.90, 0.24, 0.23, 0.15, 0.18, 0.18, 0.27, 0.82, 0.45, 0.89 and 0.45 mg/L for CLE and ten impurities respectively.