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- Title
Stability Indicating RP-HPLC Method Development and Validation of Olmesartan Medoxomil.
- Authors
Kumanan, R.; Reddy, Jitendra M.; Manasa, R.
- Abstract
Objective: Olmesarton medoximil is an angiotensin antagonist used in treatment of hypertension. The goal of present work was planned to develop accurate, precise, specific, and reproducible and stability indicating HPLC method for the estimation of Olmesartan medoxomil (OLM) in presence of its degradation products and related impurities for assessment of purity of bulk drug and stability of its dosage forms. Methods: A rapid, specific stability indicating reverse phase high performance liquid chromatography method has been developed and validated for olmesarton medoximil in pharmaceutical dosage forms. Results: The chromatographic separation was achieved on a column Luna C18 (Alkyl reversed phases) using acetonitrile: 0.05M KH2PO4 (50: 50 v/v), pH-4.5 mobile phase, flow rate was 1.0 mL/ min. The method was validated according to the regulatory guidelines with respect to precision, accuracy, linearity and limit of detection (LOD) and Limit of Quantitation (LOQ). Conclusion: Results of estimation of OLM in tablet formulation were accurate and precise with standard deviation < 2. All the validation parameters were within acceptance range.
- Subjects
ENZYME inhibitors; THERAPEUTICS; HYPERTENSION; HIGH performance liquid chromatography; DRUG dosage; ACETONITRILE; BIODEGRADATION of pharmaceutical drug carriers
- Publication
Asian Journal of Pharmaceutical & Biological Research (AJPBR), 2011, Vol 1, Issue 2, p79
- ISSN
2231-2218
- Publication type
Article