反相高效液相色谱法测定奥沙普嗪分散片中奥沙普嗪含量

Determination of Oxaprozin Content in Oxaprozin Dispersible Tablets by RP-HPLC

目的建立测定奥沙普嗪分散片中奥沙普嗪含量的高效液相色谱法。方法采用反相高效液相色谱法,以Hypersil C18柱(200 mm×4.6 mm,5μm)为色谱柱,以0.01 mol/L磷酸二氢钾溶液(磷酸调pH至2.5)-乙腈(40∶60)为流动相,检测波长为286 nm,流速为1.0 mL/min,柱温30℃。结果奥沙普嗪质量浓度在4.0～24.0μg/mL范围内与峰面积线性关系良好,高中低3种质量浓度的回收率为97.6%～101.3%,RSD为1.1%～1.8%。结论所建立的方法快速、准确、简便,适用于奥沙普嗪分散片的质量控制。

Objective To establish a RP-HPLC method for the determination of Oxaprozin content in Oxaprozin Dispersible Tablets.Methods The RP-HPLC method was adopted on the Hypersil C18 column（200 mm×4.6 mm,5 μm） with UV detection wavelength at 286 nm,and the mobile phase consisted of acetonitrile-0.01 mol/L potassium dihydrogen phosphate solution adjusted to pH=2.5 with phosphoric acid（60 ∶40）.The flow rate was 1.0 mL/min.The column temperature was 30 ℃.Results The calibration curve was linear within the range of 4.0-24.0 μg/mL for oxaprozin,the average recovery rate was 97.6%-101.3%for three different concentrations of oxaprozin,RSD was 1.1%-1.8%.Conclusion This method is rapid,simple and accurate,which is suitable for the quality control of Oxaprozin Dispersible Tablets.