DEVLOPMENT & CHARACTERIZATION OF FIMASARTAN TABLET USING UV SPECTROSCOPY

Rishabh Mittal*, Dr. Md. Semimul Akhtar and Dr. Nita Yadav

ABSTRACT

Fimasartan is the non-peptide angiotensine II receptor antagonist which is utilized in hypertension. A simple accurate & cost-effective approach is established for the estimation of Fimasartan tablet employing uv spectrophotometer in the API & bulk dose form. The Fimasartan exhibits λmax at 261 nm using 10% methanol solution. Fimasartan fulfilled Beer-Lambert’s law in the range of concentrations of 10-50μg/ml with pearson correlation (r2) of 0.999. The accuracy of the model was confirmed by percent recovery, by adding a known amount of the pure drug to the formulation and the percentage recovery was found to between 98.5 to 100.08% w/w, indicating that the developed method is accurate which indicates a good accuracy of the method and it shows that the method was free from the interference of excipients used in the formulation. The precision of the technique was provided in terms of the relative standard deviation, and it should be evaluated by utilizing a minimum of 6 determinations over 100 % concentration which reveals % RSD less than2 indicates that the procedure was exact. The limit of detection and quantification was determined to be 3 & 9.11, respectively. The percentage purity of the marketed formulation was found to be 97.18 % w/w. The suggested spectrophotometric approach was verified as per the ICH Q1A (R2) requirements.

Keywords: Fimasartan, UV spectrophotometry, linearity, method development, Validation.