HPLC法测定盐酸伊伐布雷定片含量

Determination of ivabradine hydrochloride in Ivabradine Hydrochloride Tablets by HPLC

目的建立HPLC法测定盐酸伊伐布雷定片的含量。方法采用C18Inertsil ODS-3(250mm×4.6mm,5μm)色谱柱,流动相为磷酸盐缓冲液(pH7.6)-乙腈(60∶40),流速为1.0mL.min-1,检测波长为286nm,柱温25℃。结果盐酸伊伐布雷定线性范围为2.32～16.25μg,峰面积与进样量线性关系良好(r=0.999 9);平均回收率为101.3%,其RSD为1.2%(n=9)。结论该方法准确、可靠、简便,适用于盐酸伊伐布雷定片的含量测定。

Objective To establish an HPLC method for the determination of ivabradine hydrochloride in Ivabradine Hydrochloride Tablets. Methods The column C18 Inertsil ODS-3（250 mm × 4.6 mm,5 μm） was used. The mobile phase consisted of buffer phos-phate（ pH7.6 ）- acetonitrile（ 60 ： 40 ）, flow rate was 1.0 mL ·min^-1, the detection wavelength was set at 286 nm, and the column temperature was 25 ℃. Results The linearity of peak area was good when the sample content was in the range of 2.32-16.25 μg（ r= 0. 999 9）. The average recovery was 101.3% with RSD 1.2%（n= 9）. Conclusions The method is accurate, reliable and simple, and it can be used in the determination of ivabradine hydrochloride in Ivabradine Hydrochloride Tablets.