ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF OLMESARTAN MEDOXOMIL BY RP-UPLC IN BULK AND PHARMACEUTICAL DOSAGE FORMS
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2013, Vol 1, Issue 5
Abstract
A simple rapid, accurate, precise and reproducible validated reverse phase UPLC method was developed for the determination of Olmesartan medoxomil in bulk and pharmaceutical dosage forms. The quantification was carried out using Waters acquity UPLC BEH C18 (100 X 2.1 mm, 1.7 µm) column run in Gradient way using mobile phase-A [pH 3.4 Buffer: Acetonitrile (70:30% v/v)] and mobile phase-B [pH 3.4 Buffer:Acetonitrile (30 :70 % v/v)] and a detection wavelength of 250nm, and injection volume of 4µL, with a flow rate of 0.5mL/min. The retention times of Olmesartan medoxomil was found to be 3.418. The method was validated in terms of linearity, precision, accuracy, LOD, LOQ and robustness in accordance with ICH guidelines. The linearity ranges of the proposed method lies between 0.080 mg/mL to 0.120 mg/mL, which is equivalent to 10% to 150% and with correlation coefficient of r2=0.9999.The assay of the proposed method was found to be 98.79%. The recovery studies were also carried out and mean % Recovery was found to be 100.5%. The % RSD from reproducibility was found to be <2%. The proposed method was statistically evaluated and can be applied for routine quality control analysis of Olmesartan medoxomil in bulk and in Pharmaceutical dosage form.
Authors and Affiliations
Farhana pattan, K. Haritha Pavani, A. Kiran Kumar, N. Sunny Babu, K. V. Kalyan Kumar, Chandana N
Keywords
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