A New Analytical Method Validation and Quantification of Olmesartan Medoxomil and its related impurities in bulk drug product by HPLC

A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of olmesartan Medoxomil and its related impurities. The chromatographic separations were achieved on (250×4.6 mm), 5.0 μm make: Zorbax Eclipse XDB-C8 column employing 00.1% H3PO4 in Water: Acetonitrile in the ratio of 50: 50 (v/v) as mobile phase with gradient initially A: B: 70: 30 and followed as Time/A/B: 25/30/70; 30/30/70; 31/75/25 and runtime is 35 mins at flow rate 1.0 mL/min was chosen. All impurities were eluted within 18 minutes. The column temperature was maintained at 30°C and a detector wavelength of 225 nm was employed. The method was successfully validated by establishing Specificity, Linearity, Precision, Accuracy, Limit of detection and Limit of quantification.