使用羟丙基-β-环糊精作为流动相添加剂，通过高效液相色谱法测定原料药、片剂和胶囊中的舍曲林。

HPLC determination of sertraline in bulk drug, tablets and capsules using hydroxypropyl-beta-cyclodextrin as mobile phase additive.

作者信息

Chen Deying, Jiang Shumin, Chen Yuying, Hu Yuzhu

机构信息

China Pharmaceutical University, 24 Tongjia Lane, Nanjing 210009, China.

出版信息

J Pharm Biomed Anal. 2004 Jan 27;34(1):239-45. doi: 10.1016/j.japna.2003.08.013.

DOI:10.1016/j.japna.2003.08.013

PMID:14738940

Abstract

A sensitive and stereospecific high-performance liquid chromatography (HPLC) method for determination of sertraline in bulk drug, tablets and capsules was developed. Chromatography resolution of the sertraline enantiomeric forms and trans diastereoisomers was performed on Alltima C18 (250 mm x 4.6mm i.d., 5 microm) column with hydroxypropyl-beta-cyclodextrin (HP-beta-CD) as mobile phase additive. The composition of the mobile phase was 68:32 (v/v) aqueous 170 mM phosphate buffer, pH 3.0 (adjusted with 85% phosphoric acid) containing 18 mM HP-beta-CD/acetonitrile at a flow rate of 1.0 ml x min(-1). The UV detector was set at 225 nm. Calibration curves were linear (r=0.9999, n=9) in the range of 1-120 microgml (-1) for sertraline. Limit of detection and quantitation for sertraline was 0.029 and 0.097 microg x ml (-1). The values of R.S.D. of repeatability and intermediate precision for bulk drug, tablets and capsules of sertraline hydrochloride were less than 1.0%.

摘要

建立了一种灵敏且具有立体选择性的高效液相色谱（HPLC）法，用于测定原料药、片剂和胶囊中的舍曲林。舍曲林对映体形式和反式非对映异构体的色谱分离在Alltima C18（250 mm×4.6mm内径，5微米）柱上进行，以羟丙基-β-环糊精（HP-β-CD）作为流动相添加剂。流动相的组成是68:32（v/v）的170 mM磷酸盐水溶液，pH 3.0（用85%磷酸调节），含有18 mM HP-β-CD/乙腈，流速为1.0 ml×min(-1)。紫外检测器设定在225 nm。舍曲林的校准曲线在1-120 microgml (-1)范围内呈线性（r = 0.9999，n = 9）。舍曲林的检测限和定量限分别为0.029和0.097 microg×ml (-1)。盐酸舍曲林原料药、片剂和胶囊的重复性和中间精密度的相对标准偏差值均小于1.0%。