An International, Peer-Reviewed, Open Access Multidisciplinary Pharmacy Journal

Development and validation of a stability indicating RP‑HPLC method for simultaneous estimation of Olmesartan Medoxomil and Metoprolol Succinate in pharmaceutical dosage form

Submitted by webadmin on Wed, 10/26/2016 - 12:09
Pharmaceutical Methods,2012,3,2,84-89.
Published:December 2012
Type:Original Article

Development and validation of a stability indicating RP‑HPLC method for simultaneous estimation of Olmesartan Medoxomil and Metoprolol Succinate in pharmaceutical dosage form

Nirmal M. Thakker, Haresh B. Panchal1, Dinesh R. Rakholiya1, R. Murugan1, Vishnu P. Choudhari, Bhanudas S. Kuchekar

Department of Pharmaceutical Analysis and Quality Assurance, MAEER’s Maharashtra Institute of Pharmacy, S. No. 124, MIT Campus, Ex‑serviceman Colony, Paud Road, Kothrud, Pune, Maharashtra,

1Department of Analytical Research, Zydus Research Centre, Sarkhej‑Bavla N. H. No. 8A, Moraiya, Ahmedabad, Gujarat, India

Abstract:

Aim and Backrgound: A simple, rapid, precise and isocratic RP‑HPLC (Reverse Phase High Performance Liquid Chromatography) method is aimed to develop for the simultaneous estimation of Olmesartan Medoxomil and Metoprolol Succinate in bulk drug and pharmaceutical dosage form. Materials and Methods: The quantification is carried out using YMC‑Pack CN (250 × 4.6 mm, 5.0 μm) column and the mobile phase comprises of 0.05% Trifluoro acetic acid (TFA) and Acetonitrile (ACN) (70:30 v/v). The flow rate is 1.0 ml/min. The eluent is monitored at 220 nm. The retention times of Olmesartan Medoxomil and Metoprolol Succinate are 7.9 min and 4.1 min respectively. The method is validated in terms of linearity, precision, accuracy, specificity, limit of detection and limit of quantitation. Results: Linearity and percentage recoveries of both Olmesartan Medoxomil and Metoprolol Succinate are in the range of 5‑35 μg/ml and 100 ± 2%, respectively. The stress testing of both the drugs individually and their mixture is carried out under acidic, alkaline, oxidation, photo‑stability and thermal degradation (dry heat and wet heat) conditions and its degradation products are well resolved from the analyte peaks. Conclusion: This method was successfully validated for accuracy, precision, and linearity.