HPLC法测定右旋兰索拉唑控释胶囊中左旋异构体含量  

S-isomer Determination in Dexlansoprazole Delayed Release Capsules Using an HPLC Method

作　　者：郭俊平[1] 

机构地区：[1]宜兴市人民医院,宜兴214200

出　　处：《药学与临床研究》2014年第3期228-230,共3页Pharmaceutical and Clinical Research

摘　　要：目的：建立HPLC法对右旋兰索拉唑控释胶囊中左旋和右旋异构体进行拆分并测定其中左旋异构体含量。方法：采用Chiral-AGP手性柱（4.6 mm×150 mm,5μm）;流动相为乙腈-pH 6.0磷酸盐缓冲液（10∶90）;流速0.5 mL·min-1;柱温30℃;检测波长285 nm;进样量20μL。结果：兰索拉唑左旋和右旋异构体之间的分离度为3.0,左旋异构体的线性范围为0.51~5.10μg·mL-1（r=0.9996）,检测限为2.52 ng,平均回收率（n=9）为98.4%。结论：该方法操作简便,结果准确,可用于右旋兰索拉唑控释胶囊中左旋异构体的含量测定。Objective： To establish an HPLC method for enantio-separation of S- and R- lansoprazole and quantitation of the S-isomer. Methods： The separation was performed on an AGP chiral column（DAICEL CHIRALPAK, 150 mm ×4.6 mm, 5 μm）. The mobile phase was acetonitrile-pH 6.0 sodium phosphate buffer（10∶90） at the flow rate of 0.5 mL·min-1. The column temperature was 30 ℃, and the UV detection was set at 285 nm. The injection volume was 20 μL. Results： The resolution of the isomers was3.0, the linear range of the s-isomer was 0.51~5.10 μg·mL-1（r=0.9996）, the detection limit was 2.52 ng and the average recovery（n=9） was 98.4%. Conclusion： The method is simple and accurate and can be used for S-isomer assay in dexlansoprazole delayed release capsules.

关 键 词：高效液相色谱 手性柱 右旋兰索拉唑控释胶囊 左旋异构体 

分 类 号：R927.2[医药卫生—药学]