Validation of an UV-Visible spectrophotometry assay method for the determination of chlorpheniramine maleate tablets without prior extraction

Abstract

Methods proposed by pharmacopeias to check the quality of chlorpheniramine maleate tablets are multi steps methods which involve extraction and present issues with repeatability. An alternative method is proposed with a sensitive, reliable, simple and rapid UV-VISIBLE spectrophotometry method developed for the determination without extraction of chlorpheniramine maleate in tablets. The method was validated using the accuracy profile approach with an accuracy ranging from 99.70 to 100.46%. Analysis was done using 0.25 mol/L sulfuric acid, distilled water, and raw material in a room at 23 °C for 25 to 30 minutes. Chlorpheniramine maleate concentration varied from 0.018 to 0.03 mg/mL. The method was found to be specific with the appearance of the corresponding maxima at 265 nm and a correlation coefficient (R2 ) of 0.9993. Limits of detection and quantification were respectively 1.39 × 10^-4
and 2.26 × 10^-3 mg/mL. The tolerance limits for the different concentration levels (75, 100 and 125%) were respectively: 88.37; 92.74 and
91.62% for lower limits and 111.03; 108.17 and 108.02% for upper limits. It was observed that the tolerance limits were within the limits of acceptability set at 20%. Consequently, the method was declared valid and reliable for routine analysis of chlorpheniramine maleate in tablets containing chlorphenamine as active principle.

Keywords : Chlorpheniramine maleate, tablets, accuracy profile, assay method without extraction, validation