正相色谱法测定盐酸伊伐布雷定中对映异构体

Determination of Enantiomer in Ivabradine Hydrochloride by NP-HPLC

目的:建立盐酸伊伐布雷定对映异构体检测方法。方法:采用CHIRALPAK AD-H(4.6 mm×250 mm,5μm)色谱柱,以正己烷-异丙醇-三乙胺(60∶40∶0.1)为流动相,等度洗脱,流速为0.8 mL·min^(-1),检测波长为286 nm,柱温为30℃。结果:专属性良好,对映异构体进样量在6.19~74.30 ng范围内线性关系良好,r≥0.999 5;平均回收率为94.05%,RSD小于5.0%(n=9);精密度和重复性的RSD均小于2.0%;耐用性良好。结论:方法专属性好,精密度高,准确度高,可用于本品的对映异构体检测。

A method for the determination of the enantiomers of Ivabradine Hydrochloride was established.CHIRAL-PAK AD-H(4.6×250 mm,5μm)was used as chromatographic column,n-hexane-isopropanol-triethylamine was used as mobile phase to elute equally,the flow rate was 0.5 mL·min^(-1),the detection wavelength was 286 nm and the column temperature was 30℃.The results showed that the specificity of the method was good,the enantiomers showed a good linear relationship within the range of 6.19~74.30 ng(r=0.9995),the average recovery was 94.05%,RSD was less than 5.0%(n=9),and precision and repeatability RSD was less than 2.0%.So,the method has strong specificity,good precision and high accuracy,and can be used for the determination of enantiomers of this product.