目的 建立測(cè)定丁酸氯維地平原料藥中有關(guān)物質(zhì)的RP-HPLC法。方法 采用Welchrom C₁₈色譜柱(250 mm×4.6 mm,5 μm);流動(dòng)相為甲醇-環(huán)己烷-水(70:0.5:30);體積流量為1 mL/min;柱溫為30 ℃;檢測(cè)波長(zhǎng)為240 nm;進(jìn)樣體積為20 μL。結(jié)果 丁酸氯維地平及其14種雜質(zhì)能夠達(dá)到良好的分離;丁酸氯維地平及其雜質(zhì)I、III、IV、V的質(zhì)量濃度與峰面積的線(xiàn)性關(guān)系良好;丁酸氯維地平及其14種雜質(zhì)的檢測(cè)限(S/N≥3)在0.57～3.13 ng。結(jié)論 該方法簡(jiǎn)便準(zhǔn)確、重復(fù)性好,專(zhuān)屬性強(qiáng),精密度高,可用于丁酸氯維地平原料藥中有關(guān)物質(zhì)的測(cè)定。

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 mL/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.