Simultaneous Determination of Simvastatin and Ezetimibe in Tablets by HPLC

被引:12
作者
Kumar, D. Anantha [1 ]
Sujan, D. P. [1 ]
Vijayasree, V. [1 ]
Rao, J. V. L. N. Seshagiri [1 ]
机构
[1] Andhra Univ, AU Coll Pharmaceut Sci, Visakhapatnam 530003, Andhra Pradesh, India
关键词
Simvastatin; Ezetimibe; Determination; HPLC; PERFORMANCE LIQUID-CHROMATOGRAPHY; PHARMACEUTICAL DOSAGE FORMS; HUMAN PLASMA; PRIMARY HYPERCHOLESTEROLEMIA; MASS-SPECTROMETRY; LOVASTATIN; EFFICACY; SAFETY;
D O I
10.1155/2009/626343
中图分类号
O6 [化学];
学科分类号
0703 ;
摘要
A reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of simvastatin and ezetimibe in tablet dosage forms. The separation was effected on a C18 Supelcosil column ( 250 mm x 4.6 mm; 5 mu) using a mobile phase consisting of 0.01 M ammonium acetate buffer and acetonitrile ( 35: 65 v/v) at a flow rate of 1 mL/min. The detection was made at 240 nm. The retention times for ezetimibe and simvastatin were 5.9 and 8.5 min respectively. Calibration curves were linear over the ranges of 0.5-40 mu g/mL for simvastatin and 2.5-50 mu g/mL for ezetimibe. The proposed method was validated as per the ICH and USP guidelines. The method is accurate and precise and found to be suitable for the quantitative analysis of both the drugs individually and in combination in tablet dosage forms.
引用
收藏
页码:541 / 544
页数:4
相关论文
共 12 条
[11]   Second-derivative UV spectrometric determination of simvastatin in its tablet dosage form [J].
Wang, L ;
Asgharnejad, M .
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2000, 21 (06) :1243-1248
[12]   Determination of Simvastatin in human plasma by liquid chromatography-mass spectrometry [J].
Yang, HT ;
Feng, Y ;
Luan, YW .
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2003, 785 (02) :369-375