RP-HPLC法测定赖诺普利片剂中有关物质  

Determination of Related Substances in Lisinopril Tablets by RP-HPLC

作　　者：张瑛[1] 

机构地区：[1]东南大学化学化工学院,江苏南京210096

出　　处：《药学进展》2007年第7期323-325,共3页Progress in Pharmaceutical Sciences

摘　　要：目的：建立赖诺普利片剂中有关物质的RP-HPLC检测方法，为赖诺普利片剂的质量控制提供有效的分析手段。方法：色谱柱：LichrospherCt8（150mm×4．6mm，5μm），流动相：乙腈一磷酸二氢钠缓冲液（pH5．2）（10：90），流速：1．0mL/min，检测波长：215nm，柱温：45℃，进样量：20μL。结果：赖诺普利浓度在16—260mg/mL范围内线性关系良好（r=0．9995），赖诺普利最低检测限为3．92ng，辅料对主药和降解产物的检测无影响，主药和降解产物能很好的分离检出。结论：本法准确、简便，适用于赖诺普利片剂中有关物质检测。Objective： To develop a RP-HPLC method for determination of related substances in lisinopril tablets. Methods： A Lichrospher C18 column was used with the mobile phase of acetonitrile-sedium dihydrogen phosphate solution （pH5.2） （10：90） at a flow rate of 1.0 mL/min, with a detection wavelength of 215 nm, a column temperature of 45 ℃ and a injection volume of 20μL. Results： The calibration curve for lisinopril assay exhibited an excellent linear relationship with a correlation coefficient of 0.9995 in concentration range of 16 - 260μg/mL. The detection limit was 3.92 ng for lisinopril. There was no influence of excipients on the determination of the medicine and its degradation products, which were separated and detected well. Conclusion： The method is accurate, simple and suitable for determination of related substances in lisinopril tablets.

关 键 词：反相高效液相色谱 赖诺普利片剂 有关物质 

分 类 号：R927[医药卫生—药学]