STABILITY-INDICATING RP-HPLC METHOD FOR ANALYSIS OF ATORVASTATIN IN BULK DRUG, MARKETED TABLET AND NANOEMULSION FORMULATION

被引：0
作者：
Mustafa, Gulam [1 ]
Azeem, Adnan [1 ]
Ahmad, Farhan J. [1 ]
Khan, Zeenat I. [1 ]
Shakeel, Faiyaz [2 ]
Talegaonkar, Sushma [1 ]
机构：
[1] Fac Pharm, Dept Pharmaceut, New Delhi 110062, India
[2] Al Arab Med Univ, Fac Pharm, Dept Pharmaceut, Benghazi, Libya
来源：
JOURNAL OF THE CHILEAN CHEMICAL SOCIETY | 2010年 / 55卷 / 02期
关键词：
RP-HPLC; atorvastatin; nanoemulsion; tablets; ICH guidelines; PERFORMANCE LIQUID-CHROMATOGRAPHY; HUMAN PLASMA; HUMAN SERUM; VALIDATION; ASSAY; UV; QUANTITATION; AMLODIPINE; CALCIUM;
D O I：
暂无
中图分类号：
O6 [化学];
学科分类号：
0703 ;
摘要：
A simple, highly sensitive, isocratic stability indicating reversed phase-high performance liquid chromatography (RP-HPLC) method with UV detection at 247 nm was developed and validated for analysis of atorvastatin (AT). Retention time of the AT was found to be 4.02 min. A mobile phase consisting of 0.05 M sodium phosphate buffer and methanol (3:7 v/v) pH 4.1 at flow rate of 1 mL/min was employed in this study. The calibration curves were linear with regression coefficient (r(2)) of 0.9997 +/- 0.0014. The limits of detection (LOD) and the limits of quantification (LOQ) were found to be 0.20 and 0.60 mu g/mL, respectively. The method was statistically validated in accordance with International conference on harmonization (ICH) guidelines. The proposed method was found sensitive, specific and was successfully applied for the estimation of atorvastatin in pharmaceutical formulations (bulk drug, tablet, nanoemulsion).
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页码：184 / 188
页数：5
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