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目的:建立高效液相色谱法测定酮洛芬肠溶胶囊和搽剂的含量,为质量控制提供有效的分析手段。方法:色谱柱为Venusil Mp-C18(150mm×4.6mm,5μm);流动相为乙睛-水-磷酸盐缓冲液(43:5:2);流速1.0mL.min-1;检测波长255nm,样品用流动相超声溶解,并定量稀释制成每1mL中约含酮洛芬0.1mg的溶液。结果:制剂中辅料和有关物质对主药无干扰,酮洛芬的线性范围为0.01～1g.L-1(r=1.0000);最低检测限为0.3mg.L-1;定量限为1mg.L-1;日内精密度RSD为0.54%(n=6);日间精密度RSD为0.70%(n=6);酮洛芬肠溶胶囊的平均回收率为100.6%(n=9);酮洛芬搽剂的平均回收率为101.0%(n=9)。结论:此法操作简便、灵敏、准确,重复性好,适用于酮洛芬肠溶胶囊和搽剂的含量测定。
OBJECTIVE: To establish a method for the determination of ketoprofen enteric-coated capsules and liniment by HPLC and to provide an effective analytical tool for quality control. Methods: The chromatographic column was Venusil Mp-C18 (150 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile-water-phosphate buffer solution (43: 5: 2) The sample was dissolved in the mobile phase by sonication and quantitatively diluted to give a solution containing about 0.1 mg of ketoprofen per 1 mL. Results: The excipients and related substances did not interfere with the main drug. The linear range of ketoprofen was 0.01 ~ 1g.L-1 (r = 1.0000). The limit of detection was 0.3mg.L-1. The limit of quantification was 1mg. The intra-day precision RSD was 0.54% (n = 6), the intra-day precision RSD was 0.70% (n = 6), and the average recovery of ketoprofen enteric-coated capsules was 100.6% (n = 9) The average recovery of ketoprofen liniment was 101.0% (n = 9). Conclusion: This method is simple, sensitive, accurate and reproducible. It is suitable for the determination of ketoprofen enteric-coated capsules and liniment.