RP-HPLC法测定颗粒型盐酸伊托必利的人血浆浓度

RP-HPLC DETERMINATION OF ITOPRIDE HYDROCHLORIDE IN PLASMA

目的 :建立一种测定人血浆中盐酸伊托必利血药浓度的反相高效液相色谱法。方法 :采用外标法 ,血样经乙醚—氢氧化钠混合溶剂提取后 ,以nucleosil 2 5 0mm× 4 6mm ,5 μmC18色谱柱为固定相 ,乙腈—磷酸二氢钾为流动相 ,在 2 5 7nm波长处定量检测。结果 :血药浓度在 1 0 0～ 1 6 0 0 0ng·ml- 1范围内线性关系良好 ,最低定量浓度为 1 0 0ng·ml- 1,批内、批间相对标准偏差均小于 7% ,低、中、高三个浓度的相对回收率为 1 0 2 8%～ 1 0 6 3%。检测了 2 0名健康受试者服用盐酸伊托必利后不同时间的血药浓度变化。 结论 :此方法简便、快速、精确 。

Objective:To develop a sensitive and simple reversed phase liquid chromatography method for analysis of itopride hydrochloride in human plasma Methods:Itopride hydrochloride in plasma was extracted with the mixture of ether and sodium hydroxide,then measured by HPLC using a nucleosil C 18 reverse phase column as stationary phase and acetonitrile phosphate buffer as mobile phase Itopride hydrochloride was quantified by ultraviolet absorbance at 257 nm Results:The calibration curve was linear in the range from 10 ng·ml -1 to 1600 ng· ml -1 with a regression coefficient of 0 9995 and the lowest limit of detection of itopride hydrochloride in plasma was 10 ng·ml -1 The relative standard deviation was less than 7% both inter and intra batch,and the recoveries of itopride hydrochloride at three concentration levels of low,medium and high were 102 8%～106 3% The method was used to determine itopride hydrochloride in plasma from twenty volunteers Conclusion:The results of our study demonstrate that this method is rapid and accurate and it can be applied to determination of plasma itopride concentration and to study on pharmacokinetics