Author(s)

Serigne Omar Sarr^1,2*, Eddy Kevin Senan Ouendo¹, Thierno Mouhamed Wane¹, El Hadji Assane Diop³, Diop Amadou¹, Serigne Momar Ndiaye², Rokhaya Gueye¹, Khadidiatou Thiam¹, Aminata Sarr¹, Ousmane Niass¹, Djibril Fall^2,4, Bara Ndiaye¹, Serge Rudaz³, Yérim Mbagnick Diop^1,2

¹Laboratory of Analytical Chemistry and Food Sciences, Cheikh Anta Diop University, Dakar, Senegal.
²National Medicines Control Laboratory, Ministry of Health, Dakar, Senegal.
³Laboratory of Pharmaceutical Analytical Chemistry, School of Pharmacy, Geneva, Switzerland.
⁴Laboratory of Organic and Therapeutic Chemistry, Cheikh Anta Diop University, Dakar, Senegal.

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.

Analytical Validation, Chlorphenamine Maleate, Quality, Capillary Electrophoresis, CEB, Senegal

Sarr, S. , Ouendo, E. , Wane, T. , Diop, E. , Amadou, D. , Ndiaye, S. , Gueye, R. , Thiam, K. , Sarr, A. , Niass, O. , Fall, D. , Ndiaye, B. , Rudaz, S. and Diop, Y. (2016) Validation of a Capillary Electrophoresis Method for Analyzing Chlorphenamine Maleate-Based Drugs Using the Accuracy Profile Approach. American Journal of Analytical Chemistry, 7, 452-459. doi: 10.4236/ajac.2016.75042.