HPLC法检测尼美舒利干混悬剂的有关物质

Determination of Impurities for Nimesulide Dry Suspensions by HPLC

目的:应用高效液相色谱法检测尼美舒利干混悬剂的有关物质。方法:色谱条件:C18柱,乙腈-磷酸二氢铵溶液(1.15g·L-1,用氨试液调节pH值至7.0)(50∶50)为流动相,检测波长为230nm。结果:该法检测限为0.14mg·L-1,重复性试验RSD为0.8%。结论:该方法简便、灵敏、准确。

Objective： To detect the impurities in Nimesulide Dry Suspension by HPLC. Methods： The analysis was performed on a C18 column. The mobile phase was a mixture of 50 volumes of acetonitrile and 50 volumes of the 1, 15 g · L^ -1 solution of ammonium dihydrogen phosphate adjusted to pH 7.0 with ammonia. The detection wavelength was set at 230 nm. Results： The limit of detection was 0. 14 mg · L^ -1. The repeatability was good （ RSD = 0. 8% ）. Conclusion： The method was simple, practicable and accurate.