高效液相色谱法分析卡贝缩宫素及其有关杂质

HPLC analysis of carbetocin and its related impurities

目的:应用反相高效液相色谱法分析卡贝缩宫素及其有关杂质,并对有关杂质进行定位。方法:用 Lichrospher(?) 100 RP-C_(18)(125 mm×4 mm,5μm)色谱柱,流动相为磷酸盐缓冲液(pH 7.0)-乙腈(76:24);流速为1.2 mL·min^(-1);柱温为60℃,检测波长为220 nm。结果:卡贝缩宫素在0.25～8.0μg范围内呈良好的线性关系,r=1.000,最低检测限为2 ng,平均回收率为99.3%,各有关杂质的相对保留时间范围为相对保留时间±0.02。结论:本法简便、准确,适用于卡贝缩宫素的定量及其有关杂质的鉴别。

Objective ： An RP - HPLC method was established for the determination of carbetocin. Method： Used RP- HPLC column C ls （125 mm Х 4 mm,5 μm）and phosphate buffer- acetonitrile （76： 24） as mobile phase, flow rate of 1.2 mL · min^-1, column temperature was 60 ℃ , the detection wavelength was at 220 nm. Results ： The calibration curve of carbetocin in good linearity over the range of 0.25 - 8.0 μg, r = 1. 000. The average recovery was 99.3 %. The range of relative retention time of any impurity was relative retention time ± 0.02. Conclusion： This method is simple and accurate for the assay of carbetocin and also suitable to identify of related impurity.