ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ASSAY FOR OLMESARTAN MEDOXOMIL IN FORMULATED PRODUCT BY REVERSE PHASE ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY
Tapeesh Bharti*, Rakhi Mishra, Chatrasal Singh Rajput and Richa Singhal
ABSTRACT
The novel approach was carried out to develop and validate a rapid and selective analytical method by using
Reverse Phase Ultra performance Liquid Chromatography (RP-UPLC) technique for the analysis of Olmesartan
Medoxomil in raw materials & their pharmaceutical dosage forms. The developed analytical UPLC method is
superior in technology to conventional HPLC method with respect to speed, resolution, solvent consumption and
cost of analysis. The compound was analyzed with a total run time of 3.5min. (in reverse phase) at 215nm
wavelength. Optimum retention was achieved on Waters Acquity UPLC BEH C18 column (2.1 × 30mm, 1.7μm)
using gradient elution with mobile phase i.e. 5mM Ammonium Acetate in water (volatile reagent) and Acetonitrile
as organic solvent. The Olmesartan Medoxomil was first dissolved in Acetonitrile and the final dilution was done
by using Water: Acetonitrile (30:70) v/v as diluents. The method showed excellent recoveries for all drugs in bulk.
The developed UPLC method was validated with respect to specificity, linearity, precision, accuracy, ruggedness
(reproducibility), robustness and stability. The test solution was found to be stable in diluents for 24hrs when
stored at RT (i.e. 25°C). Recovery data was in the range of 98.82% to 99.76%. The method is economical in terms
of the time taken and the amount of solvent used, thus promoting green chemistry concept. To the best of our
knowledge, a work on method development and validation of Olmesartan Medoxomil by using RP-UPLC
technique, disclosed in this investigation, was not published elsewhere.
Keywords: Olmesartan Medoxomil, UPLC, new method development, validation.
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