RP-HPLC法测定利培酮口腔崩解片中主药及有关物质的含量

Determination of main component and the related substances in risperidone orally disintegrating tablets by RP-HPLC

目的建立反相高效液相色谱法测定利培酮口腔崩解片中主药及有关物质含量。方法色谱柱为Kromasil C18,流动相为甲醇-乙腈-0.1mol/L醋酸胺水溶液,检测波长为279nm,流速为1ml/min,柱温为30℃,进样量为20μl。结果利培酮检测浓度的线性范围为2.123～53.075μg/ml(r=0.9999);平均回收率为100.1%(RSD=0.3%)。结论本方法简便、准确、专属性强,可用于该制剂的质量控制。

Objective To establish a method for the determination of risperidone and its related substances in risperidone orally disintegrating tablets. Methods RP-HPLC was performed on a C18 column using methanol-acetonitrile-0, 1mol/L acetic acid amine as the mobile phase at a flow rate of 1ml/min. The detection wavelength was at 279nm. The Column temperature was 30℃ and the sample size was 20μl. Results The linear range of risperidone was 2. 123 - 53. 075μg/ml （ r = 0. 9999 ）, the average recovery was 100.1% （ RSD = 0.3% ）. Conclusion The method is simple, accurate, special and can be used for the quality control of risperidone orally disintegrating tablets.