title: 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.
abstract: A simple, sensitive, and rapid liquid chromatographic method was developed and validated using diode array detection for the determination of five commonly used antimalarial drugs in pharmaceutical formulations and in human plasma. Chromatographic separation of antimalarial drugs and internal standard (ibuprofen) was achieved on a C18 column with a mobile phase composed of 10 mM dipotassium orthophosphate at pH 3.0, methanol, and acetonitrile in a ratio of 20:38:42 v/v, at a flow rate of 1 mL/min. The analytes were monitored at 220 nm and separated in ˂10 min. The method was validated for linearity, accuracy, precision, limit of quantification, and robustness. Both intra- and interday precisions (in terms of %RSD) were lower than 3% and accuracy ranged from 98.1 to 104.5%. Extraction recoveries were ≥96% in plasma. The limits of quantitation for artemether, lumefantrine, pyrimethamine, sulfadoxine, and mefloquine were 0.3, 0.03, 0.06, 0.15, and 0.15 μg/mL in human plasma. Stability under various conditions was also investigated. The method was successfully applied for quantification of antimalarial drugs in marketed formulations and in spiked human plasma. The method can be employed for routine QC purposes and in pharmacokinetic investigations.
authors.affiliation: Department of Pharmaceutical Analysis, JSS University, Udhagamandalam, Tamil Nadu, India.|Department of Pharmacy, Annamalai University, Annamalai Nagar, Tamil Nadu, India.
authors.forename: Sai Sandeep
authors.initials: SS
authors.lastname: Mannemala
authors.affiliation: Department of Pharmaceutical Analysis, JSS University, Udhagamandalam, Tamil Nadu, India.
authors.forename: Janaki Sankarachari Krishnan
authors.initials: JS
authors.lastname: Nagarajan
mesh_terms: D000962:Antimalarials / Q000032:analysis* / Q000097:blood; D000077549:Artemether; D037621:Artemisinins / Q000032:analysis* / Q000097:blood; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004983:Ethanolamines / Q000032:analysis* / Q000097:blood; D005449:Fluorenes / Q000032:analysis* / Q000097:blood; D064368:Healthy Volunteers; D006801:Humans; D000078102:Lumefantrine; D015767:Mefloquine / Q000032:analysis* / Q000097:blood; D011739:Pyrimethamine / Q000032:analysis* / Q000097:blood; D015203:Reproducibility of Results; D013413:Sulfadoxine / Q000032:analysis* / Q000097:blood; D013607:Tablets
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004983:Ethanolamines; D005449:Fluorenes; D013607:Tablets; D013413:Sulfadoxine; D000077549:Artemether; D000078102:Lumefantrine; D015767:Mefloquine; D011739:Pyrimethamine
keywords: Antimalarial drugs; Bioanalytical methods; Fractional factorial design; High-performance liquid chromatography; Human plasma