Abstract

A NEW ANALYTICAL METHOD DEVELOPMENT & VALIDATION FOR THE ESTIMATION OF OLMESARTAN MEDOXOMIL AND CILNIDIPINE IN ITS PHARMACEUTICAL DOSAGE FORM BY UPLC AS PER ICH GUIDE LINES

K. Santhosh Nayak* and K. Pramod

Abstract

A simple, accurate, precise, sensitive, rapid UPLC method has been developed and validated for determination of Olmesartan medoxomil and Cilnidipine in its pharmaceutical dosage form. Chromatographic separation was achieved on a BEH C18 column(100 ×2.1mm,1.7), by a mobile phase consisted of Ph3.5 buffer, maintained with ortho phosphoric acid and methanol in 35:65(V/V) ratio with a flow rate of 0.3 ml/min. The detection wavelength was set at 254 nm. Olmesartan medoxomil and Cilnidipine was subjected to different stress conditions. The degradation products, when any, were well resolved from the pure drug with significantly different retention time values. The method was linear (r = 0.999) at a concentration range of 0.2-0.3μg/ml. The intra and inter day precisions were satisfactory; the relative standard deviations did not exceed 2%. The accuracy of the method was proved; the mean recovery of Olmesartan medoxomil and Cilnidipine was 99.04- 101.58%. The proposed method has high throughput as the analysis involved short run-time (3.20 mins). The method met the ICH/FDA regulatory requirements. The proposed method was successfully applied for the determination of Olmesartan medoxomil and Cilnidipine with acceptable accuracy and precisions; The results demonstrated that the method can be applied successfully for routine use in quality control industry laboratories.

Keywords: Olmesartan medoxomil and Cilnidipine, UPLC.