Abstract

ANALYTICAL METHOD DEVELOPMENT FOR THE ESTIMATION OF OLMESARTAN AND AMLODIPINE BISILATE COMBINATION IN TABLET DOSAGE FORM BY USING HPLC METHOD

Premlata Bhura*, Ankit Diwan, Ganesh Patel and Dr. Kuldeep Ganju

ABSTRACT

The aim and objective of the present work is to develop new simple, sensitive, economic and validated RP-HPLC method for the simultaneous estimation of amlodipine besylate and olmesartan medoxomil in marketed formulation. Amlodipine besylate and olmesartan medoxomil are a white and white to light yellow amaurphus powder melts on 202-202 oC and 175-176 oC respectively. UV scanning between 200-400 nm λmax of Amlodipine was found at 239nm and λ max of olmesartan was found to be 256 nm. Three isosbestic points were found in overlain spectra of Amlodipine and Olmesartan that were 235nm, 242nm, and 308.5 nm. 235 nm was selected for further studies. Phosphate buffer: Acetone in 90:10 ratios were selected as mobile phase, flow rate 1.0 ml/min. Retention time of Olmesartan and Amlodipine was found at 13.106 and 14.243 min respectively. Validation of developed Analytical method will be according to ICH guideline. Method was validated on different parameters like Linearity and Calibration curve (y = 11264x + 71391 (R2= 0.997) for Amlodipine and y = 10337x + 40214 (R2= 0.998) for Olmesartan), LOD (olmesartan 0.0054091 & Amlodipine 0.0016675) and LOQ (olmesartan 0.0163916 Amlodipine 0.0050529), Accuracy (% Recovery more than 99.5 for both drugs), Precision (mean % Recovery more than 99.5 for both drugs), Ruggedness and Robustness. All validation parameter are under limits that suggested by ICH guideline.

Keywords: Amlodipine besylate, olmesartan medoxomil, validation, method development, RP-HPLC.