TITLE:
Validation of a Capillary Electrophoresis Method for Analyzing Chlorphenamine Maleate-Based Drugs Using the Accuracy Profile Approach
AUTHORS:
Serigne Omar Sarr, Eddy Kevin Senan Ouendo, Thierno Mouhamed Wane, El Hadji Assane Diop, Diop Amadou, Serigne Momar Ndiaye, Rokhaya Gueye, Khadidiatou Thiam, Aminata Sarr, Ousmane Niass, Djibril Fall, Bara Ndiaye, Serge Rudaz, Yérim Mbagnick Diop
KEYWORDS:
Analytical Validation, Chlorphenamine Maleate, Quality, Capillary Electrophoresis, CEB, Senegal
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.7 No.5,
May
19,
2016
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