拉西地平片中有关物质的含量测定及初步确证  

Determination and identification of related substances in lacidipine tablets

作　　者：胡英娟 王丽 申兰慧 

机构地区：[1]江苏省无锡市药品检验所,江苏无锡214028

出　　处：《中南药学》2014年第11期1122-1125,共4页Central South Pharmacy

摘　　要：目的建立高效液相色谱法测定拉西地平片有关物质。方法采用C18色谱柱,流动相:甲醇-水(75:25);柱温:35℃;检测波长:283 nm;流速:1.0 m L·min-1。采用UPLC/Q-TOF-MS对有关物质进行质谱定性。结果在该色谱条件下拉西地平与有关物质分离度良好,能有效检测出拉西地平的降解产物及合成中带入的杂质,并经质谱进行初步确证。结论该方法能够简便、灵敏、准确的检测出拉西地平的有关物质。Objective To establish a HPLC method to determine and identify the related substances in lacidipine tablets. Methods The C18 column was used. The mobile phase was composed of methanol and water. The flow rate was 1.0mL·min^- 1. The detective wavelength was 283 nm and the column temperature was 35 ℃. UPLC/Q-TOF-MS was used to identify the molecular structure of related substances. Results The related substances were completely separated from lacidipine. The degradation products and impurities in synthesis were determined by HPLC. ConclusionThe method is simple, sensitive and accurate for determination of related substances in lacidipine tablets.

关 键 词：拉西地平片 有关物质 高效液相色谱法 UPLC/Q-TOF-MS 

分 类 号：R917[医药卫生—药物分析学]