Simultaneous Determination of Atorvastatin Calcium and Telmisartan in Pharmaceutical Formulations by Reverse Phase-High Performance Liquid Chromatography

Abstract

ABSTRACT:A simple, sensitive and reproducible reverse-phase high performance liquid chromatographic (RP-HPLC) method has been developed for simultaneous quantitative estimation of Atorvastatin calcium (ATOR) and Telmisartan (TELM) in the pharmaceutical formulations. Chromatographic separation was achieved on a 250 × 4.6 mm, 5µ, Waters symmetry column. The flow rate was 1ml/min and eluent was monitored by absorbance at 267 nm using a mixture of Methanol and Acetonitrile (pH 3.0±0.01) in the ratio of 25:75 (v/v). The retention time of Atorvastatin calcium and Telmisartan was found to be 5.6 and 8.2 min respectively. Calibration plots were linear in the concentration range of 5-25 µg/ml for Atorvastatin calcium and 10-50 µg/ml for Telmisartan with correlation coefficient (R 2 ) 0.999 respectively. The proposed method was validated by testing its linearity, recovery, specificity, system suitability, precision (Interday, intraday, analyst and instrument precision), robustness and LOD/LOQ values and it was successfully employed for the determination of Atorvastatin calcium and Telmisartan in pharmaceutical tablet formulations.

Optimization of a forced degradation study of atorvastatin employing an experimental design approach

“…The literature data have shown that atorvastatin, like most of the statins, is a very unstable molecule and the analytical processing of this active ingredient is still a current problem. Also, reviewed literature data include only a few studies, where the instability of atorvastatin in hydrolytic, oxidative or photolytic condition was mentioned as a part of the selectivity of the stability-indicating methods [18][19][20][21][22][23][24][25][26][27][28][29][30]. To date, to the best of our knowledge, none of the reported analytical procedures describe a simple and satisfactory sample preparation methodology where the influence of the stressor straight, time of expose and temperature are evaluated in detail.…”