普拉格雷含量及有关物质的测定

摘要

A HPLC method for determination of the content of Prasugrel and its related substances was es-tablished.The chromatographic conditions were conducted as follows:Diamonsil C18 column(150 mm×4.6 mm, 5μm)with the temperature of 30 ℃,mobile phase consisting of acetonitrile∶phosphate buffer (pH value 5.0) in the volume ratio of 50∶50,the flow rate of 1.0 mL·min-1 ,the detection wavelength of 219 nm,the injection volume of 10μL .The calibration curve for Prasugrel was linear in the range of 0.5~3.0μg·mL-1 .The aver-age of recovery rate was 99.95%(n=9).The method was rapid,simple,accurate,sensitive and suitable for de-termination of the content of Prasugrel and its related substances.%采用 HPLC法测定了普拉格雷原料药含量和有关物质。色谱条件如下：色谱柱为 C18柱（150 mm×4.6 mm，5μm），柱温30℃，流动相为乙腈-磷酸盐缓冲溶液（pH 值5.0）（50∶50，体积比），流速1.0 mL·min-1，检测波长219 nm，进样量10μL。结果表明：普拉格雷在0.5～3.0μg·mL-1范围内，线性关系良好，平均加样回收率为99.95％（n＝9）。此法操作简便、快速、灵敏、准确，样品处理简便易行，可用于测定普拉格雷原料药含量和有关物质。