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

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.

High performance liquid chromatographic separation of eight drugs collected in Chinese Pharmacopoeia 2010 on amylose ramification chiral stationary phase

The enantiomers separation of ei ght pharmaceutical racemates collected in Chinese Pharmacopoeia 2010(Ch.P2010),including nitrendipine,felodipine,omeprazole,praziquantel,sulpiride,clenbuterol hydrochloride,verapamil hydrochloride and chlorphenamine maleate,was performed on chiral stationary phase of amylose ramification by high performance liquid chromatography(HPLC)on Chiralpak AD-H column and Chiralpak AS-H column with the mobile phase consisted of isopropanol and n-hexane.The detection wavelength and the flow rate were set at 254 nm and 0.7 mL/min,respectively.The effects of proportion of organic additives,alcohol displacer and temperature on the separation were investigated.The results indicated that eight chiral drugs were separated on chiral stationary phase of amylase ramification in normal phase chroma tographic system.The chromatographic retention and resolution of enantiomers were adjusted by factors,including the changes of the concentration of alcohol displacer in mobile phase,organic alkaline modifier and column temperature.It was shown that the resolution was improved with reducing concentration of alcohol displacer.When the concentration of organic alkaline modifier was 0.2%,the resolution and the peak shape were fairly good.Most racemates mentioned above had the best resolution at column temperature of 25℃.The best temperature should be kept unchanged in the process of separation so as to obtain stable separation results.