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目的:采用高效液相色谱法测定右旋布洛芬缓释栓中右旋布洛芬含量及有关物质。方法:色谱柱ODS-C_(18)柱(250mm×4.6mm,5um);以乙腈-0.02mol·L~(1-)磷酸二氢钾溶液(pH2.50)(53:47)为流动相;检测波长为264nm。结果:线性范围为4～128mg·L~(-1)(r=1.0000),平均回收率为99.9%,RSD为0.3%(n=9)。结论:方法重复性好,准确度高,适于右旋布洛芬缓释栓的质量控制。
OBJECTIVE: To determine the content of dexibuprofen and related substances in dexibuprofen sustained-release suppository by high performance liquid chromatography. METHODS: The mobile phase consisted of ODS-C 18 column (250 mm × 4.6 mm, 5 μm) and acetonitrile-0.02 mol·L -1 potassium dihydrogen phosphate solution (pH 2.50) ; Detection wavelength of 264nm. Results: The linear range was 4 ~ 128 mg · L -1 (r = 1.0000). The average recovery was 99.9% and the RSD was 0.3% (n = 9). Conclusion: The method has good repeatability and high accuracy, and is suitable for the quality control of dexibuprofen sustained-release suppository.