Abstract
Green RP-HPLC method for a rapid analysis of olmesartan medoxomil (OLM) in bulk drugs, self-microemulsifying drug delivery system (SMEDDS) and marketed tablets was developed and validated in the present investigation. The chromatographic identification was achieved on Lichrosphere 250×4.0mm RP C8 column having a 5μm packing as a stationary phase using a combination of green solvents ethyl acetate:ethanol (50:50% v/v) as a mobile phase, at a flow rate of 1.0mL/min with UV detection at 250nm. The proposed method was validated for linearity, selectivity, accuracy, precision, reproducibility, robustness, sensitivity and specificity. The utility of the proposed method was verified by an assay of OLM in SMEDDS and commercial tablets. The proposed method was found to be selective, precise, reproducible, accurate, robust, sensitive and specific. The amount of OLM in SMEDDS and commercial tablets was found to be 101.25% and 98.67% respectively. The proposed method successfully resolved OLM peak in the presence of its degradation products which indicated stability-indicating property of the proposed method. These results indicated that the proposed method can be successfully employed for a routine analysis of OLM in bulk drugs and commercial formulations.
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