DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF CILNIDIPINE AND OLMESARTAN MEDOXOMIL IN BULK AND TABLET DOSAGE FORM BY HPTLC

Abstract

Cilnidipine and Olmesartan medoxomil in combined dosage form has been developed and validated. Sample and standard solutions of Cilnidipine and Olmesartan medoxomil were applied to precoated silica gel G 60 F254 HPTLC plates and the plates were developed with Methanol: Toluene: Ethyl acetate: Acetic acid in the ratio 2.5: 5.5: 2.0: 0.1 (v/v/v/v) as mobile phase. The Rf value for cilnidipine and Olmesartan medoxomil was found to be 0.66 and 0.43 respectively The detection was performed at 254 nm. The calibration curve was found to be linear between 100 to 200 ng/spot for cilnidipine and 200 to 400 ng/spot for Olmesartan medoxomil with correlation coefficients 0.995 and 0.996 for Cilnidipine and Olmesartan medoxomil respectively. The LOD and LOQ were found to be 23.057ng/spot and 69.86 ng/spot for Cilnidipine and 39.18ng/spot and 118.750 ng/spot for Olmesartan medoxomil respectively. The results have been validated statistically as per ICH guidelines.