高效液相色谱法测定帕潘立酮缓释片含量

目的建立反相HPLC法测定帕潘立酮缓释片的含量,并研究用不同的溶剂和提取方法比较帕潘立酮的提取效率。方法采用Waters Symmetry C18（250 mm×4.6 mm,5μm）色谱柱,流动相：0.05 mol·L-1磷酸二氢铵缓冲液-甲醇（55：45,v/v）,检测波长：283 nm,用0.01 mol·L-1HCl溶液超声提取制备供试品溶液。结果帕潘立酮在12.1～120.8μg·mL-1线性关系良好（r=0.999 9）,方法重复性（RSD=0.6%）和平均回收率（99.7%,n=9）均较好,样品溶液在室温放置24 h内稳定。结论本方法简便、准确,适用于帕潘立酮缓释片的含量测定。

Determination of paliperidone extended-release tablets by HPLC

Objective To establish an HPLC method for the content determination of paliperidone extended-release tablets.Methods Chromatographic separation was performed with Waters Symmetry C18 column（250 mm×4.6 mm,5 μm）,0.05 mol·L-1 ammonium dihydrogen phosphate solution-methanol（55 ： 45,v/v） as the mobile phase and detection wavelength was 283 nm.The extraction procedure of paliperidone was developed by studying different solvents（water,HCl,NaOH,acetonitrile and methanol） and extraction techniques（ultrasonic bath and magnetic stir）.Results The linear range of paliperidone was 12.1-120.8 μg·mL-1（r = 0.999 9）;the repeatability（RSD =0.6%） and average accuracy（99.7%,n=9） were acceptable.The sample solution was stable for 24 h at room temperature.Conclusion The method is simple,accurate,and can be successfully applied in the content determination of paliperidone extended-release tablets.