The online version of this article (doi:10.1186/1475-2875-11-149) contains supplementary material, which is available to authorized users.
The authors declare that they have no competing interests.
NCA: study design, sample preparation, data collection, analysis and interpretation of data, drafting of manuscript. M-DB and MA: study design and manuscript preparation. JM: technical contribution. HF: conception of the study, supervision on the progress of the study and revision of the manuscript. All authors read and approved the final manuscript.
Quality control of drugs in formulations is still a major challenge in developing countries. For the quality control of artesunate and amodiaquine tablets in fixed-dose combination, only liquid chromatographic methods have been proposed in the literature. There are no capillary electrophoretic methods reported for the determination of these active substances, although this technique presents several advantages over liquid chromatography (long lifetime, low price of the capillary, low volumes of electrolyte consumption) in addition to simplicity. In this paper, a reliable capillary electrophoresis method has been developed and validated for the quality control of these drugs in commercial fixed-dose combination tablets.
Artesunate and amodiaquine hydrochloride in bilayer tablets were determined by micellar electrokinetic capillary chromatography (MEKC). Analytes were extracted from tablets by sonication with a solvent mixture phosphate buffer pH 7.0-acetonitrile containing benzoic acid as internal standard. Separation was carried out on Beckman capillary electrophoresis system equipped with fused silica capillary, 30 cm long (20 cm to detector) × 50 μm internal diameter, using a 25 mM borate buffer pH 9.2 containing 30 mM sodium dodecyl sulfate as background electrolyte, a 500 V cm−1 electric field and a detection wavelength of 214 nm.
Artesunate, amodiaquine and benzoic acid were separated in 6 min. The method was found to be reliable with respect to specificity,linearity of the calibration line (r2 > 0.995), recovery from synthetic tablets (in the range 98–102%), repeatability (RSD 2–3%, n = 7 analytical procedures). Application to four batches of commercial formulations with different dosages gave content in good agreement with the declared content.
The MEKC method proposed is reliable for the determination of artesunate and amodiaquine hydrochloride in fixed-dose combination tablets. The method is well-suited for drug quality control and detection of counterfeit or substandard medicines.
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World Health Organization: Guidelines for the treatment of malaria. 2010, WHO Press, Geneva, Switzerland, 13-34. Second
Lacaze C, Kauss T, Kiechel J-R, Caminiti A, Fawaz F, Terrassin L, Cuart S, Grislain L, Navaratnam V, Ghezzoul B, Gaudin K, White NJ, Olliaro PL, Millet P: The initial pharmaceutical development of an artesunate/amodiaquine oral formulation for the treatment of malaria: a public-private partnership. Malar J. 2011, 10: 142-10.1186/1475-2875-10-142. PubMedCentralCrossRefPubMed
Phadke MU, Jadhav VK, Jadhav RK, Dave SS, Patil DS: Simultaneous RP-LC determination of artesunate and amodiaquine in pharmaceutical preparations. Chromatographia. 2008, 68: 1003-1007. 10.1365/s10337-008-0800-6. CrossRef
Gandhi S, Deshpande P, Jagdale P, Godbole V: A simple and sensitive RP-HPLC method for simultaneous estimation of artesunate and amodiaquine in combined tablet dosage form. J Chem Pharm Res. 2010, 2: 429-434.
D’Hulst A, Augustijns P, Arens S, Parijs LV, Colson S, Verbeke N, Kinget R: Determination of artesunate by capillary electrophoresis with low UV detection and possible applications to analogues. J Chromatogr Sci. 1996, 34: 276-281. CrossRef
Altria KD, Clarck BJ, Kelly MA: Investigation into the effects of sample dissolving solvents and sample matrices on the separations obtained in capillary electrophoresis. Part II. MECC. J High resolution Chromatogr. 1999, 22: 55-58. 10.1002/(SICI)1521-4168(19990101)22:1<55::AID-JHRC55>3.0.CO;2-B. CrossRef
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use. Validation of analytical procedures: Text and methodology. 2005, Topic Q2 (R1), Geneva
Marini RD, Rozet E, Montes MLA, Rohrbasser C, Roht S, Rhème D, Bonnabry P, Schappler J, Veuthey JL, Hubert P, Rudaz S: Reliable low-cost capillary electrophoresis device for drug quality control and counterfeit medicines. J Pharm Biomed Anal. 2010, 53: 1278-1287. 10.1016/j.jpba.2010.07.026. CrossRefPubMed
Taylor P: Study backs capillary electrophoresis as anti-counterfeit medicine tool. http://wwwsecuringpharmacom/study-backs-capillary-electrophoresis-as-anti-counterfeit-medicine-tool/s40/a1107/:SecuringPharma.com; 11-Nov-2011
- Capillary electrophoresis for the assay of fixed-dose combination tablets of artesunate and amodiaquine
N’Cho Christophe Amin
- BioMed Central
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