Development and validation of new UV-spectrophotometric methods for analysis of bosentan in different simulated body fluid media

Abstract

In the present study a simple, accurate, precise, economical, reproducible and specific UV- Spectrophotometric method for estimation of bosentan (BST) in simulated body fluid and in pharmaceutical formulations has been developed. The drug shows the same, maximum λ_max at 269 nm in different media. The correlation coefficient (r²) of linearity range of developed methods in range of 3-30 μg/ml of drug were found to be 0.9963, 0.9967, 0.9914 and 0.9947 in distilled water, simulated tears, phosphate buffer and in methanol respectively. The reproducibility of presented method was found to be within the range i.e. less than 2% RSD. The limit of detection (DL) were found to be 1.30 μg/ml, 0.12 μg/ml, 2.02 μg/ml and 0.15 μg/ml where as limit of quantification (QL) were found to be 3.97 μg/ml, 0.37 μg/ml, 0.57 μg/ml and 0.48 μg/ml respectively in different- different solvent system. The proposed method was validated statically according to ICH guidelines in reference to specificity, linearity, range, accuracy, precision and robustness. Thus proposed method were validated and found to be accurate and specific for the estimation of BST in bulk, in pharmaceutical formulations and in simulated fluids.