RP-HPLC Analytical Method Development and Validation for the Determination of Olmesartan Medoxomil in Bulk Drug and Tablets


Olmesartan medoxomil
ICH validation


A simple, economic, accurate, sensitive and precise reverse phase high performance liquid chromatographic (RP-HPLC) method for the determination of Olmesartan Medoxomil in bulk drug and tablet dosage form was developed and validated as per the ICH Harmonised Tripartite Guideline. The chromatographic separation was carried out on Hypersil GOLD C18 column (150mm × 4.6mm, 5μm ) with acetonitrile and phosphate buffer pH 3 (35:65%) containing 1% of glacial acetic acid at a flow rate of 1.2mL/min and the PDA detection set at 255nm. A linear response was observed over the concentration from 5μg/mL to 25μg/mL (r2 = 0.9999). The recoveries were found to be between 99.47% - 100.35% and the corresponding RSDs between 0.52-0.68. The validation data proved that the assay undergone is sensitive, reproducible and economical and thus can be used for the routine estimation of Olmesartan medoxomil in bulk drug and tablets dosage form.


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