高效液相色谱法同时测定奥湿克片中两组分的含量及有关物质

 目的：测定奥湿克片中米索前列醇和双氯芬酸钠的含量及有关物质)方法：采用RP-HPLC，用岛津Shim-Pack CLC-C〈sub〉8〈/sub〉柱((4.6 mm×15 mm，5 μm；流动相：乙腈-甲醇-pH 3.0缓冲液(22：36：42)，检测波长：200 nm，有关物质B型米索前列醇(SC-33188)280 nm。结果：米索前列醇和双氯芬酸钠分别在10.2～163.2μg·ml〈sup〉-1〈/sup〉(r=0.9995，n=9)和1.29～20.6μg·ml〈sup〉-1〈/sup〉(r=0.9997，n=9)浓度范围内呈线性关系。米索前列醇和双氯芬酸钠的平均回收率(n=6)分别为100.0%，100.6%；RSD分别为0.6%，0.7%，同时测定米索前列醇的有关物质。结论：方法简便、准确。

RP-HPLC simultaneouly determination of diclofenac sodium,misoprostol and its related impurities in compound misoprostol tablet

OBJECTIVE:To develop an assay for the determination of diclofenac sodium,misoprostol and misoprostol related impurities in compound misoprostol tablet.METHODS:A RP-HPLC was used on Shim-Pack CLC-C-8 column with a mobile phase of acetonitrile methanol pH 3.0 triethylamine buffer(22∶36∶42) and the detection wavelength at 200 nm(SC-33188 at 280 nm).RESULTS:The standard curves for misoprostol and diclofenac sodium were linear over the range of 10.2～163.2 μg·ml^-1(r=0.9995,n=9);1.29～20.6 μg·ml^-1(r=0.9997,n=9),respectively.The average recoveries of misoprostol and diclofenac sodium were 100.0%,100.6%;with RSD-0.6%,0.7%,respectively.Diclofenac sodium,misoprostol and its related impurities could be determined simultaneously.CONCLUSION:The method is convenient,accurate and precise.