Abstract

A RP-HPLC-BASED ANALYTICAL METHOD WAS DEVELOPED AND VALIDATED SIMULTANEOUSLY FOR ROSUVASTATIN AND OLMESARTAN MEDOXOMIL IN COMBINED TABLET DOSAGE FORM

R. Babu* and Dr. P. Kalaiselvi

ABSTRACT

A useful, easy and validated reverse-phase high performance liquid chromatography (RP-HPLC) technique was established to estimate Rosuvastatin and Olmesartan Medoxomil in combination drug dosage forms. The technique involved use of a C18 column or column, and the mobile phase consisted of acetonitrile and sodium dihydrogen phosphate (pH 4) which was optimized. The analysis was conducted using a UV detector by means of running the separation at a flow rate of 1.0 mL/min and an analysis of wavelength of 240 nm. The system was highly linear (correlation coefficient values of 0.9996 and 0.9991, respectively, for Rosuvastatin and Olmesartan Medoxomil), accurate (recovery percentage yield of 99.28 and 98.70, respectively, of Rosuvastatin and Olmesartan Medoxomil) and precise (RSD values compared of 0.44 and 0.35, respectively). The technique was found to be very robust because the parameters, including the flow rate and temperature, displayed little variation. Moreover, the LOD and LOQ were also determined to be 0.56μg/mL and 1.72 μg/mL of Rosuvastatin and 0.72 μg/mL and Olmesartan Medoxomil,respectively. The established RP-HPLC technique can be used in the routine analysis and control of these drugs in formulations.

Keywords: RP-HPLC, Rosuvastatin, Olmesartan Medoxomil, validation, pharmaceutical dosage forms.