METHOD DEVELOPMENT AND VALIDATION OF RP-UPLC METHOD FOR THE ESTIMATION OF AMLODIPINE AND OLMESARTAN MEDOXOMIL IN TABLET FORMULATION
Shweta Rajendra Yadav* and Dr. Shailesh B. Patil
ABSTRACT
A new simple, accurate, precise and reproducible gradient phase ultra-performance liquid chromatography method was developed and fully validated for the estimation of Amlodipine Besylate and Olmesartan Medoxomil in pharmaceutical tablet dosage form gradientlly using acetonitrile: triethylamine buffer(pH4.0+0.5) as mobile phase and Acquity BEH C8 column (4.6x 150 mm,2.6?g) as stationary phase and chromatogram was recorded at 237nm at a flow rate of 0.4ml/min. The retention time of AML were 1.5to 2.8 and OLM 3.2 to 5.5 min respectively and showed a good linearity in the concentration range of 5-25?g/ml with a concentration coefficient (R) of 0.99956 and 0.99985 respectively. The developed UPLC method was validated with respect to specificity, linearity, precision, accuracy, ruggedness (reproducibility), robustness and stability. The recovery data was in the range of 98.0%to 102.0%. the proposed method was validated as per ICH guidelines and successfully as per ICH guidelines and successfully applied to the development and validation of AML and OLM in tablet formulation.
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