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

被引：50

作者：

Chen, DY ^{[1
]}

Jiang, SM ^{[1
]}

Chen, YY ^{[1
]}

Hu, YZ ^{[1
]}

机构：

[1] China Pharmaceut Univ, Nanjing 210009, Peoples R China

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2004年 / 34卷 / 01期

关键词：

sertraline; enantiomer; hydroxypropyl-beta-cyclodextrin; bulk drug; tablets; capsules;

D O I：

10.1016/j.japna.2003.08.013

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

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 C 18 (250 mm x 4.6 mm i.d., 5 mum) 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 min(-1). The UV detector was set at 225 nm. Calibration curves were linear (r = 0.9999, it = 9) in the range of 1-120 mug ml(-1) for sertraline. Limit of detection and quantitation for sertraline was 0.029 and 0.097 mug 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%. (C) 2003 Elsevier B.V. All rights reserved.

引用

页码：239 / 245

页数：7

共 16 条

[1] Assay of sertraline in tablets and drug substance by liquid chromatography [J].