HPLC法测定盐酸多培沙明含量及有关物质

Determination of dopexamine hydrochloride and its related substances using a HPLC method

目的:采用高效液相色谱法测定盐酸多培沙明含量及有关物质。方法:色谱柱为VP-ODS C_(18)柱(150 mm×4．6 mm,5μm),流动相为50 mmol·L^(-1)枸橼酸溶液(含50 mmol·L^(-1)枸橼酸钠)-乙腈(90:10),流速为1 mL·min^(-1),检测波长为280 nm。结果:盐酸多培沙明的线性范围为4～600μg·mL^(-1)(r=0．999 98),平均回收率为99．92％(RSD为0．26％);各杂质峰与主峰达到基线分离。结论:本方法简便、快速,结果准确,重复性好。

Objective：To establish a HPLC method for determining dopexamine hydrochloride and its related substances. Methods：Analysis was performed using C18 chromatographic column（150 mm× 4.6 mm, 5 μm）. The mobile phase was consisted of 50 mmol· L^- 1 citric acid containing 50 mmol· L^- 1 sodium citrate and acetonitrile（90： 10, v/v）with a flow rate at 1.0 mL· min^-1. The detection wavelength was set at 280 nm. Results：The calibration curve of dopexamine hydrochloride was constructed in the range of 4 - 600 μg· mL^1 （ r = 0. 999 98）. The average recovery was 99.92% and RSD 0.26%. The chromatographic peaks of dopexamine hydrochloride and its related substances were well isolated. Conclusion：A simple, accurate and rapid HPLC method is developed for determining dopexamine hydrochloride and its related substances.