高效液相色谱法测定盐酸伊托必利胶囊的含量

Determination of Itopride Hydrochloride Capsule By HPLC

目的 :建立盐酸伊托必利胶囊的含量测定方法。方法 :用高效液相色谱法测定 ,选用C18 分析柱(4.6mm×250mm ,10μm) ,流动相 :甲醇—水—三乙胺—冰醋酸(40∶60∶0.5∶0.3) ,检测波长 :258nm ;流速 :1ml/min ,灵敏度 :0.6AUFS。结果 :最低检出量为0.2μg/ml,线性范围 :19.98～199.8μg/ml,相关系数r=0.9991 ,平均回收率100.3 %(n=5) ,RSD为0.34 %。结论 :建立的定量方法可用于盐酸伊托必利胶囊的质量控制标准。

Purpose: To establish a method for determination of the content of Itopride Hydrochloride capsule. Method: The HPLC method has been utilized with the C18 column (4.6mm×250mm) as the stationary phase; the mobile phase consisted of Methanol-Water-Triehanolamine-Glacial ascetic acid (with the proportion of 40∶60∶0.5∶0.3); the detection wave-length was selected at 258nm and the flow rate was 1ml/min with sensitivity as 0.6AUFS. Results: The minimum concentration limit was 0.2(g/ml; a good linearity displayed over the range of 19.98～199.8 μg/ml, r=0.9991; the average recovery rate was 100.3%(n=5), RSD=0.34%. Conclusion: The established method is reliable and can be served as a quality control criterion for Itopride Hydrochloride capsule.