Method Development and Validation of simultaneous estimation for Amlodipine besylate and Olmesartan medoxomil by HPTLC method

Abstract

The present work deals with method development and analytical validation of a novel, precise and accurate HPTLC methods for the simultaneous estimation of Amlodipine besylate and Olmesartan medoxomil. Literature review has shown that High performance liquid chromatography and UV- Visible Spectroscopy methods have been reported for the estimation of these drugs, but no HPTLC method has been done, thus this study had to be done. An analytical method development for the simultaneous estimation of Amlodipine besylate and Olmesartan medoxomil was developed. For simultaneous HPTLC method, the analytical separation was achieved on aluminium plates pre-coated with Silica Gel 60 F254 Acetonitrile: Water: Toluene (6:3:1) v/v/v used as the mobile phase with densitometric scanning at 270 nm. Good and acceptable linearity was obtained for the drug in the range of 5 - 15 μg/mL with r2 > 0.999. All the precision measurements made were well within the acceptable limits. The percentage recovery was found to be 99.59 & 99.61 % HPTLC method for Amlodipine besylate and Olmesartan medoxomil respectively. The parameters of validation were in accordance with the outlined ICH guidelines for method development in the estimation of drugs. Hence in conclusion the method can be applied day today lab practice for the determination of Amlodipine besylate and Olmesartan medoxomil simultaneously using HPTLC instrument.