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Determination of related substances in clevidipine butyrate bulks drug by RP-HPLC
Author(s): 
Pages: 1446-1450
Year: Issue:  12
Journal: World Phytomedicines

Keyword:  clevidipine butyraterelated substancesHPLC;
Abstract: Objective To establish an RP-HPLC method for determination of related substances in clevidipine butyrate bulks drug. Methods The separation was performed on a Welchrom C18 column(250 mm × 4.6 mm, 5 μm) with methanol- cyclohexane- water(70∶0.5∶30) as mobile phase. The detection wavelength was set at 240 nm and the injection volume was 20 μL at the flow rate of 1.0 m L/min. The column temperature was 30 ℃. Results Clevidipine butyrate and 14 kinds of its impurities could be achieved good separation. There were good linear relationships of clevidipine butyrate and impurity I, III, IV, and V between concentration and peak, and the detection limits(S/N ≥ 3) were 0.57 — 3.13 ng. Conclusion This method is simple, accurate, reproducible, specific, and suitable for the determination of related substances in clevidipine butyrate bulks drug.
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