VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ATORVASTATIN CALCIUM AND OLMESARTAN MEDOXOMIL IN TABLET DOSAGE FORM
D. J. Kalena*, C. N. Patel
Department of Quality Assurance,
Shri Sarvajanik Pharmacy College,
Near arvind baug, Mehsana - 384 001, Gujarat, India
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.
Reference Id: PHARMATUTOR-ART-1159
Atorvastatin calcium (AT), [R- (R*, R*)]-2-(4-fluorophenyl)-β, δ-dihydroxy-5-(1 Methyl ethyl)-3-phenyl-4-[(phenyl amino) carbonyl] 1Hpyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate, is a white crystalline powder, slightly soluble in water and ethanol and freely soluble in methanol. AT is a HMG-CoA reductase inhibitor. HMG-CoA reductase catalyzes the reduction of 3-hydroxy-3-methyl glutaryl-coenzyme A (HMG-CoA) to mevalonate, which is the rate-limiting step in hepatic cholesterol biosynthesis[1, 2]. It is official in Indian pharmacopoeia. Olmesartan medoxomil (OLM), [2, 3?dihydroxy?2?butenyl 4?(1?hydroxy?1?methyl ethyl) ?2?propyl? 1?[p?(o?1H?tetrazol?5?yl phenyl) benzyl] imidazole?5?carboxylate, cyclic 2, 3?carbonate] is a white to yellow white crystalline powder, insoluble in water and sparingly soluble in methanol. OLM is an angiotensin II receptor blocker (ARB).
It blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle[2, 4, 5]. Several analytical methods that have been reported for the estimation of AT in biological fluids and/or pharmaceutical formulations include spectrophotometric [6, 7], high performance liquid chromatography [8-10]], while OLM determinations have been reported by UV?Vis spectrophotometry [13, 14, 15], HPLC [16-19] and HPTLC . However there is no method available for the simultaneous determination of AT and OLM in combined fixed dosage form. Therefore, an attempt was made to develop a rapid, economic and sensitive method for the simultaneous determination of AT and OLM. To access the reproducibility and wide applicability of the developed method, it was validated as per ICH norm, which is mandatory, also.
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