Development of Acid–Base Titrimetric Method for Determination of Bisoprolol Fumarate in Raw Material and Tablet Dosage Form

Abstract

A simple acid-base titrimetric method has been developed for determination of bisoprolol fumarate in pure and tablet dosage form by the reaction of previously neutralized alcoholic solution of the drug with an aqueous solution of sodium hydroxide in 1: 2 molar ratios, respectively, using phenolthalein as visual acid - base indicator. The method was found to be applicable in the range of 10 – 50 mg. All validation parameters were conducted according to the ICH guidelines, and the method was found to be accurate and precise with RSD % less than 2. The added excipients didn’t interfere in the proposed procedure as confirmed by recovery studies using standard addition technique with the recovery % 97.4 – 100.8 and RSD% 1.9. The results obtained by the developed method were validated statistically by comparing it with those of reference method by applying the t-test and F-test. The developed method can be used for determination of bisoprolol fumarate in pure and tablet dosage form.