This study aimed at validating an analytical method, using the accuracy profile approach, for the assay of chlorphenamine maleate by capillary electrophoresis. The validation was done using concentrations ranging between 75% and 125% of the target concentration of 600 mg/ml. Validation standards were prepared separately in triplicate for each series. Studied validation criteria were selectivity, linearity, trueness, precision (repeatability and intermediate precision), accuracy and limits of detection and quantification. The method was selective, with recoveries ranging between 99.55% and 99.84%. The relative standard deviations of repeatability and intermediate precision were <5%. The accuracy profile confirmed the performance of the assay method between 75% and 100% of the target concentration of 600 mg/ml. The detection and quantification limits were 5 mg/l and 15 mg/l respectively. This ecological and economical method was applied to identify and quantify chlorphenamine maleate in 3 samples of chlorphenamine maleate-based drugs provided by the Senegalese National Medicines Control Laboratory. All analyzed samples were in accordance with official standards.
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 × 10-4and 2.26 × 10-3 mg/mL. The tolerance limits for the different concentration levels (75, 100 and 125%) were respectively: 88.37; 92.74 and91.62% 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
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