VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ATORVASTATIN CALCIUM AND OLMESARTAN MEDOXOMIL IN TABLET DOSAGE FORM
About Author:
D. J. Kalena*, C. N. Patel
Department of Quality Assurance,
Shri Sarvajanik Pharmacy College,
Near arvind baug, Mehsana - 384 001, Gujarat, India
ABSTRACT
Combination therapy of Atorvastatin calcium (AT) and Olmesartan medoxomil (OLM) is used for the treatment of coexisting essential hypertension and hyperlipidemia in adult persons. In the present study a simple, precise, rapid, efficient and reproducible reversed?phase high performance liquid chromatography (RP?HPLC) method has been developed for the simultaneous estimation of AT and OLM present in its tablet dosage forms. Chromatographic separations were carried out isocratically at 30°C ± 0.5°C on a Kromasil C18 Column (5 μm, 250mm x 4.60mm) with a mobile phase composed of Methanol: Acetonitrile: Water (pH 3.65) in the ratio of 50:27:23 % v/v at a flow rate of 1.0 ml/min. Detection is carried out using a UV detector at 260 nm. The retention times for AT and OLM were 5.3 ± 0.5 min and 3.4 ± 0.5 min respectively. The linearity range for AT and OLM were found to be 10?60 μg/ml and 20?120μg/ml with correlation coefficient of 0.996 and 0.999 respectively. The %recovery of the proposed method was found in the range of 98.36-100.91 for AT and 99.27-100.99 for OLM. The relative standard deviations for three replicate measurements in three concentrations of standard solution were always less than 2%. The results of the study showed that the proposed RP?HPLC method is simple, rapid, precise and accurate, which may be useful for the routine estimation of AT and OM in bulk drug and in its pharmaceutical dosage form.
