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目的采用高层液相色谱法对盐酸伊伐布雷定及其片剂中的其他物质含量进行测定的方法进行研究分析。方法抽取同一批次的盐酸伊伐布雷定片剂,对盐酸伊伐布雷定进行分析过程中,采用正己烷-异丙醇作为流动相,浓度比为60:40,柱温控制在25℃,流速控制在0.8mL/min,检测波长选择286nm;对片剂中的其他成分进行分析时,采用乙腈-磷酸盐缓冲液作为流动相,其中磷酸盐缓冲液的pH值为7.6,浓度比为40:60,柱温控制在25℃,流速控制在1.0mL/min,检测波长选择220nm。结果盐酸伊伐布雷定异构体测量过程中,检测限为2.34ng,定量限为25ng,RSD水平为1.24%。适应性试验中盐酸伊伐布雷定与相邻峰之间的分离度为1.86,有关物质测定的平均值为0.56%。结论采用高层液相色谱法对盐酸伊伐布雷定及其片剂中的其他物质含量进行测定,具有准确方便、简单可靠的特点,可以作为今后对盐酸伊伐布雷定片剂进行质量检测和评定的常规方法,值得使用和广泛推广。
OBJECTIVE To study the method of determining the content of other substances in ivabradine hydrochloride and its tablets by high performance liquid chromatography. Methods The same batch of ivabradine hydrochloride tablets was taken and n-hexane-isopropanol was used as the mobile phase in the analysis of ivabradine hydrochloride. The concentration ratio was 60:40, the column temperature was controlled at 25 ℃, The flow rate was controlled at 0.8mL / min and the detection wavelength was selected at 286nm. When the other components in the tablets were analyzed, acetonitrile-phosphate buffer was used as the mobile phase. The pH value of phosphate buffer was 7.6 and the concentration ratio was 40 : 60, column temperature control at 25 ℃, flow rate control at 1.0mL / min, detection wavelength selection 220nm. Results During the measurement of ivabradine hydrochloride isomers, the detection limit was 2.34ng, the limit of quantification was 25ng, and the RSD level was 1.24%. In the adaptive test, the separation between ivabradine hydrochloride and its adjacent peak was 1.86, and the average of the relevant substances was 0.56%. Conclusion High-performance liquid chromatography for the determination of ivabradine hydrochloride and other tablets in tablets has the characteristics of being accurate and convenient, simple and reliable, and can be used as the quality inspection and assessment for the future ivabradine hydrochloride tablets The conventional method, it is worth to use and widely promoted.