Spectrophotometric method development and validation for determination of chlorpheniramine maleate in bulk and controlled release tablets

ABSTRACT

Spectrophotometric technique is considered to be the simplest and operator friendly among other available analytical methods for pharmaceutical analysis. The objective of the study was to develop a precise, accurate and rapid UV-spectrophotometric method for the estimation of chlorpheniramine maleate [CPM] in pure and solid pharmaceutical formulation. Drug absorption was measured in various solvent systems including 0.1N HCl [pH 1.2], acetate buffer [pH 4.5], phosphate buffer [pH 6.8] and distil water [pH 7.0]. Method validation was performed as per official guidelines of ICH, 2005. High drug absorption was observed in 0.1N HCl medium with lambdamax of 261nm. The drug showed the good linearity from 20 to 60microg/mL solution concentration with the correlation coefficient linear regression equation Y= 0.1853 X + 0.1098 presenting R2 value of 0.9998. The method accuracy was evaluated by the percent drug recovery, presents more than 99% drug recovery at three different levels assessed. The % RSD value