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使用(2-羟丙基)-β-环糊精通过毛细管电泳法测定依托度酸的对映体杂质

Determination of enantiomeric impurity of etodolac by capillary electrophoresis using (2-hydroxypropyl)-beta-cyclodextrin.

作者信息

Dung Phan Thanh, Ko Mi Young, Choi Hyun Ju, Sin Kwan Seog, Kim Kyeong Ho

机构信息

College of Pharmacy, Kangwon National University, Chuncheon, 200-701, Korea.

出版信息

Arch Pharm Res. 2008 Sep;31(9):1218-23. doi: 10.1007/s12272-001-1292-4. Epub 2008 Sep 20.

Abstract

A capillary electrophoresis method was developed to determine the impurity of etodolac enantiomers. (2-Hydroxypropyl)-beta-cyclodextrin (HP-beta-CD) was used as a chiral selector and ketoprofen as an internal standard to improve the peak area precision. The seperation of the etodolac enantiomers was achived within 35 min at 15 degrees C and its highest resolution was about 4.0 using phosphate buffer (0.1 M, pH 6.0) with 15 mM HP-beta-CD and UV detection at 225 nm with a reference wavelength at 360 nm. This method allowed determination of 0.2% of (R)-(-)-etodolac in (S)-(+)-etodolac and method validation showed adequate linearity over the required range.

摘要

建立了一种毛细管电泳法来测定依托度酸对映体的杂质。以(2-羟丙基)-β-环糊精(HP-β-CD)作为手性选择剂,酮洛芬作为内标物以提高峰面积精密度。依托度酸对映体在15℃下35分钟内实现分离,使用含有15 mM HP-β-CD的磷酸盐缓冲液(0.1 M,pH 6.0),在225 nm处进行紫外检测,参比波长为360 nm时,其最高分辨率约为4.0。该方法能够测定(S)-(+)-依托度酸中0.2%的(R)-(-)-依托度酸,方法验证表明在所需范围内具有足够的线性。

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