Informatics Publishing Limited

Celina Nazareth ¹, Shefali Naik ¹, Anwesha Dourado ¹

Affiliations
1 Department of Pharmaceutical Chemistry, P. E. S’s Rajaram and Tarabai Bandekar College of Pharmacy, Farmagudi, Goa - 403401, IN

Abstract

A simple and rapid reversed phase high performance liquid chromatographic method has been developed for the simultaneous estimation of Amlodipine and Atorvastatin in tablet dosage form. The separation was achieved on a Waters Symmetry C-18 column, (150mm × 3.9mm × 5μ particle size) using Acetonitrile: KH₂PO₄ buffer (pH 5.8) in the proportion of 45:55, v/v as mobile phase, at a flow rate of 1.0 mL/min. Detection was carried out at 254nm using VW detector. Amlodipine and Atorvastatin gave a retention time of 2.2±0.2 min and 3.2±0.2 min respectively. The developed method was validated for specificity, linearity, accuracy, precision and robustness as per ICH guidelines. The method was found to be specific as there was no interference seen in blank and placebo injections at the retention time of the drugs. The calibration curves were found to be linear with r² = 0.999 for both the drugs. The method was found to be accurate as the mean percent recovery of Amlodipine and Atorvastatin was within the acceptance criteria. The method was found to be precise with %RSD less than 2. The method was found to be robust as small, deliberate changes in chromatographic conditions did not alter the results of analysis significantly. The method was applied in analysis of marketed formulation and the % assay was found to be within limits.

Keywords

Amlodipine, Atorvastatin, RP-HPLC, Validation, Simultaneous Estimation, Tablet Dosage Form.

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Sushmita Sawant ¹, Celina Nazareth ¹, Saumya Vernekar ¹

Affiliations
1 Department of Pharmaceutical Chemistry, P.E.S.’s Rajaram and Tarabai Bandekar College of Pharmacy, Farmagudi, Goa,, IN

Abstract

Cilnidipine is a novel, dihydropyridine class of calcium-channel blocker. It prevents intracellular calcium influx and results in vasodilatation. Olmesartan medoxomil is a synthetic imidazole derivative prodrug and angiotensin II type blocker used to manage hypertension. The combination of cilnidipine and olmesartan medoxomil is used in the treatment of hypertension. Literature review revealed that there are many analytical methods involving HPLC and some using UV for estimation of the two drugs individually and in combination. UV spectrophotometric methods have the advantage of being simple, cost effective and rapid. Hence it was thought worthwhile to develop a simple, cost effective UV spectrophotometric method for simultaneous estimation of cilnidipine and olmesartan medoxomil employing the Absorption Correction principle. In this method, water: methanol (80:20,v/v) was used as the diluent. From the UV overlain spectra of both the drugs 257nm and 365nm were selected as wavelengths for analysis. The method was validated using the ICH guidelines. The linearity range was established from 10-100μg/ml (r²= 0.999) for cilnidipine and 10-80 μg/ml (r²= 0.998) for olmesartan medoxomil. The developed method was found to be accurate as % recovery at 80%, 100% and 120% levels were found to be within the acceptance criteria. The results for intra-day and inter-day precision were within acceptance limits of % RSD ˂ 2%. The method was found to be sensitive and robust. The developed method was applied in the estimation of Cilnidipine and Olmesartan in tablet dosage form and % assay was found to be 100.75% and 103.8% for the two drugs respectively. Hence the developed method can be employed as a simple, cost effective, quality control analytical method for simultaneous estimation of the two drugs in bulk and in combination.

Keywords

Cilnidipine, Olmesartan medoxomil, UV spectroscopy, Absorption Correction method, Validation, ICH guidelines.

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