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

Serigne Omar Sarr,Yérim Mbagnick Diop,Ousmane Niass,El Hadji Assane Diop,Aminata Sarr,Diop Amadou,Eddy Kevin Senan Ouendo,Serge Rudaz,Khadidiatou Thiam,Bara Ndiaye,Serigne Momar Ndiaye,Djibril Fall,Thierno Mouhamed Wane,Rokhaya Gueye

doi:10.4236/ajac.2016.75042

Serigne Omar Sarr, Yérim Mbagnick Diop + Show 12 more

Open Access

https://doi.org/10.4236/ajac.2016.75042

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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.

Highlights

Counterfeit medicines pose a public health hazard, waste consumer income and endanger stability of health systems in developing countries [1]
Chlorphenamine maleate standard and diclofenac were provided by the Senegalese National Medicines Control Laboratory (LNCM, 39 Avenue Pasteur, Dakar)
A total of 3 chlorphenamine maleate based-drug samples were taken from the Senegalese National Medicines Control Laboratory (LNCM, Dakar) and used to apply the proposed method

Summary

Introduction

Counterfeit medicines pose a public health hazard, waste consumer income and endanger stability of health systems in developing countries [1]. It is estimated that this phenomenon reaches about 10% of the global medicines market. The proportion of counterfeit medicines could reach 50%. The regular use of counterfeit or substandard medicines can lead to therapeutic failure, drug resistance or death. In some cases, it can cause death. According to WHO South-East Asia region, in 2001, 38% of 104 antimalarial drugs sold in pharmacies did not contain active ingredient [2]

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