HPLC法检测盐酸度洛西汀中有关物质及对映异构体  

Isolation of related substances and enantiomer of Duloxetine Hydrochloride by HPLC

作　　者：潘端锦[1,2] 沈卫阳[1,2] 陈蓉[1,2] 

机构地区：[1]中国药科大学分析化学教研室,南京210009 [2]药物质量与安全预警教育部重点实验室,南京210009

出　　处：《海峡药学》2010年第5期67-69,共3页Strait Pharmaceutical Journal

摘　　要：目的建立了HPLC法检查盐酸度洛西汀的有关物质及对映异构体。方法测定有关物质时采用SHI M-PACK VP-ODS柱,以0.05mol.L-1磷酸二氢钾溶液(用磷酸调至pH2.5)-(甲醇∶四氢呋喃,35∶10)(50∶50)为流动相,检测波长230 nm。对映体检查时采用CHIRAL CELOD-RH色谱柱,以0.01 mol.L-1磷酸二氢钾溶液(用磷酸调至pH2.3)-乙腈(65∶35)为流动相,检测波长230 nm。结果与结论在选定的色谱条件下,盐酸度洛西汀与盐酸左旋度洛西汀及有关物质分离完全,可用于本品的质量控制。OBJECTVE HPLC methods were established for the determination of related substances and enantiomer in duloxetine hydrochloride.METHODS For thetest of related substances,chromatography was carried out on a SHIM-PACK VP-ODS column with the mobile phase of 0.05 mol·L^-1 phosphate buffer（adjusted to pH 2.5 by phosphoric acid）-（methanol：tetramethylene oxide,35∶10）（50∶50） at the detection wavelengths of 230 nm.RESULTS AND CONCLUSION For the isolation of enantiomers of duloxetine hydrochloride,a CHIRAL CEL O-RH column was used with the mobile phase of 0.01 mol·L^-1 phosphate buffer（adjusted to pH2.3 by phosphoric acid）-acetonitrile（65∶35） at the detection wavelength of 230 nm.Under the established chromatographic conditions,duloxetine hydrochloride,the related substances and its（-）-enantiomer can be separated completely.

关 键 词：盐酸度洛西汀 有关物质 对映体 高效液相色谱 

分 类 号：R927.2[医药卫生—药学]