HPLC、UPLC测定利培酮片中有关物质的比较研究

A Comparison of determination of related substances in risperidone tablets by HPLC and UPLC

目的比较利培酮片中有关物质的两种测定方法。方法分别用高效液相色谱(HPLC)、超高效液相色谱(UPLC)测定利培酮片中利培酮的有关物质,比较两种方法的分离情况、专属性、线性、检出限和定量限、精密度和样品测定结果,并比较不同厂家利培酮片的测定结果。结果 UPLC的分析时间明显小于HPLC,二者的分离情况、线性、精密度无明显差异;UPLC的检出限和定量限低于HPLC;样品的测定结果相近,但HPLC偏低。结论 UPLC相比HPLC提高了分析效率,具有更高的分离能力,是快速分析的理想选择。

Objective To compare the methods for determination of related substances in risperidone tablets. Methods We determina ted the related substances in risperidone tablets by HPLC and UPLC respectively and compared the separation, specificity, linear range, sensitivity, precision and the impurity contents of samples by the two methods. Several risperidone tablets from different manufacturers were determined by HPLC and UPLC. Results The analysis time of UPLC was obviously shorter than that of HPLC. There were no sig nificant differences among separation, linear range, and precision. UPLC was more sensitive than HPLC. The determination results of samples by two methods were close, while those determined by HPLC were lower. Conclusion UPLC improves the analysis efficiency, with higher resolution, which is the ideal choice of quick analysis.