高效液相色谱法拆分盐酸舍曲林片的光学异构体

Separation of Four Optical Isomers Determination of Sertraline Hydrochloride Tablets by HPLC

目的建立测定盐酸舍曲林片光学异构体的高效液相色谱法。方法采用反相高效液相色谱法,以外标法测定。色谱柱为依利特Hypersil ODS2柱(150 mm×4.6 mm,5μm),流动相为磷酸二氢钠缓冲液(取磷酸二氢钠12.5 g,β-环糊精12.8 g,HP-β-环糊精17.3 g,加水至1 000 mL)-乙腈-三乙胺[800∶200∶10,用磷酸调节pH为(2.5±0.5)]为流动相,流速为1.0 mL/min,检测波长为214 nm。结果所建立的流动相能拆分盐酸舍曲林4个光学异构体,光学异构体之间的分离度均良好。结论该方法专属性好,准确、灵敏,盐酸舍曲林异构体与主峰分离良好,可作为控制盐酸舍曲林片有关物质检查的方法。

Objective To establish a HPLC method for determining four optical isomers in Sertraline Hydrochloride Tablets.Methods RP-HPLC was adopted with the external standard method for detection.The separation was carried out on the Hypersil ODS2 column（150 mm × 4.6 mm,5 μm） with the mobile phase of sodium dihydrogen phosphate buffer（taking sodium dihydrogen phosphate 12.5 g,beta-cyclodextrin 12.8 g,hydroxypropyl-beta-cyclodextrin 17.3 g and adding water to 1 000 mL）-acetonitrile-triethylamine（800 ∶ 200：10,adjusting to pH 2.5 ± 0.5 with phosphoric acid）.The flow rate was 1.0 mL / min and the detection wavelength was 214 nm.Results Four optical isomers of sertraline hydrochloride were effectively separated by the established the mobile phase.The degree of separation among isomers was good.Conclusion This method is specific,accurate and sensitive with better separation of isomers from main peak,and can be used as the detection method for controlling the related substances of Sertraline Hydrochloride Tablets。