American Journal of Analytical Chemistry

Volume 7, Issue 5 (May 2016)

ISSN Print: 2156-8251   ISSN Online: 2156-8278

Google-based Impact Factor: 1.27  Citations  h5-index & Ranking

Validation of a Capillary Electrophoresis Method for Analyzing Chlorphenamine Maleate-Based Drugs Using the Accuracy Profile Approach

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DOI: 10.4236/ajac.2016.75042    2,163 Downloads   2,683 Views   Citations

ABSTRACT

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.

Cite this paper

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.

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