Development of a generic micellar electrokinetic chromatography method for the separation of 15 antimalarial drugs as a tool to detect medicine counterfeiting

Abstract

Since antimalarial drugs counterfeiting is dramatically present on the African market, the development of simple analytical methods for their quality control is of great importance. This work consists in the CE analysis of 15 antimalarials (artesunate, artemether, amodiaquine, chloroquine, piperaquine, primaquine, quinine, cinchonine, mefloquine, halofantrine, sulfadoxine, sulfalen, atovaquone, proguanil, and pyrimethamine). Since all these molecules cannot be ionized at the same pH, MEKC was preferred because it also allows separation of neutral compounds. Preliminary experiments were first carried out to select the most crucial factors affecting the antimalarials separation. Several conditions were tested and four parameters as well as their investigation domain were chosen: pH (5-10), SDS concentration (20-90 mM), ACN proportion (10-40%), and temperature (20-35°C). Then, the experimental design methodology was used and a central composite design was selected. Mathematical modeling of the migration times allowed the prediction of optimal conditions (29°C, pH 6.6, 29 mM SDS, 36% ACN) regarding analyte separation. The prediction at this optimum was verified experimentally and led to the separation of 13 compounds within 8 min. Finally, the method was successfully applied to the quality control of African antimalarial medicines for their qualitative and quantitative content.

Capillary zone electrophoresis for the determination of amodiaquine and three of its synthetic impurities in pharmaceutical formulations

“…In the recent literature , two MEKC methods have been reported for the analysis of amodiaquine ( 4 ) and artesunate in pharmaceutical formulations. One uses a 25 mM borate buffer at pH 9 and 30 mM of sodium dodecyl sulfate (SDS) ; the second one utilizes a 10 mM phosphate buffer at pH 6.6 with 30 mM SDS and 36% of acetonitrile (v/v), operating at 29°C .…”

Development and validation of a generic liquid chromatographic method for the simultaneous determination of five commonly used antimalarial drugs: Application to pharmaceutical formulations and human plasma

“…Lamalle et al. developed a generic micellar electrokinectic chromatographic method for the separation of 15 antimalarial drugs. The reported method does not include the determination of LFT and electrophoretic methods cannot be employed for routine QC due to economic considerations.…”

Development and validation of a generic stability‐indicating MEEKC method for five fluoroquinolone antibiotics

“…Recently, a generic MEEKC method was successfully developed and applied for the analysis of 15 different antimalarials . This is a great benefit for the practical work particularly in resource‐constrained settings because a testing laboratory would only need one inventory of supplies catering for all 15 drug products instead of having 15 inventories for each individual API.…”