高效液相色谱法测定盐酸伊伐布雷定缓释片中有关物质的含量  

HPLC determination of related substances in ivabradine hydrochloride sustained-release tablets

作　　者：王肖 崔祥祯 解元元 杨永 张贵民 WANG Xiao;CUI Xiang-zhen;XIE Yuan-yuan;YANG Yong;ZHANG Gui-min(Lunan Pharmaceutical Group Co.,Ltd.,National Engineering and Technology Research Center for Chirality Pharmaceutics,Linyi Shandong 273400)

机构地区：[1]鲁南制药集团股份有限公司,国家手性制药工程技术研究中心,山东临沂273400

出　　处：《中南药学》2025年第3期740-744,共5页Central South Pharmacy

摘　　要：目的建立HPLC测定盐酸伊伐布雷定缓释片中有关物质含量的方法。方法采用Ultimate XB C18色谱柱(4.6 mm×250 mm,5μm),流动相A为0.02 mol·L^(-1)磷酸二氢铵溶液(用氨水调节pH至7.6),流动相B为乙腈,采用梯度洗脱,流速1.0 mL·min^(-1),柱温25℃,检测波长220 nm,进样体积20μL。结果杂质L、杂质B、杂质I、杂质C、杂质D、杂质H、杂质E、杂质J和伊伐布雷定的质量浓度分别在0.18~3.59、0.12~2.41、0.18~3.64、0.13~2.52、0.11~2.30、0.30~6.07、0.12~2.33、0.28~5.64、0.30~6.07μg·mL^(-1)内与峰面积呈良好的线性关系(r>0.9990);8个杂质的回收率为88.84%~107.15%,其RSD值均小于10%;8个杂质和伊伐布雷定的定量限为0.11~0.30μg·mL^(-1),检测限为0.028~0.075μg·mL^(-1)。结论本法专属性强、灵敏度高、准确度高、简便耐用,可用于盐酸伊伐布雷定缓释片的生产控制及有关物质测定。Objective To establish an HPLC method to determine the related substances in ivabradine hydrochloride sustained-release tablets.Methods Ultimate XB C18 column(4.6 mm×250 mm,5μm)was used.Mobile phase A was 0.02 mol·L^(-1) ammonium dihydrogen phosphate solution(pH adjusted to 7.6 with ammonia),and mobile phase B was acetonitrile.Gradient elution was used,the flow rate was 1.0 mL·min^(-1),the column temperature was 25℃,the detection wavelength was 220 nm,and the injection volume was 20μL.Results Impurity L,B,I,C,D,H,E,J and ivabradine showed good linearity with the peak area(r>0.9990)in the concentration ranges at 0.18~3.59,0.12~2.41,0.18~3.64,0.13~2.52,0.11~2.30,0.30~6.07,0.12~2.33,0.28~5.64 and 0.30~6.07μg·mL^(-1).The average recoveries of the above 8 impurities ranged 88.84%~107.15%,with RSD less than 10%.The quantitation limits of the 8 impurities and ivabradine ranged 0.11~0.30μg·mL^(-1),and the detection limits ranged 0.028~0.075μg·mL^(-1).Conclusion The method is exclusive,sensitive,accurate and durable.It can be used for the production control and related substances determination of ivabradine hydrochloride sustained-release tablets.

关 键 词：盐酸伊伐布雷定缓释片 HPLC 有关物质 

分 类 号：R927[医药卫生—药学]