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Simultaneous Determination of Artesunate and Amodiaquine in Fixed-Dose Combination by a RP-HPLC Method with Double UV Detection: Implementation in Interlaboratory Study Involving Seven African National Quality Control Laboratories |
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| Authors: | Y Le Vaillant C Brenier Y Grange A Nicolas P A Bonnet L R Massing-Bias P Rakotomanga B Koumaré A Mahly M Absi M Ciss M H Loueslati D Chauvey |
| Institution: | 1. Direction des laboratoires et des contr?les, Agence fran?aise de sécurité sanitaire des produits de santé, 634 rue de la Garenne, 34740, Vendargues Cedex, France 10. Direction des Laboratoires et des Contr?les, Agence Fran?aise de Sécurité Sanitaire des Produits de Santé, CS 60007, 34748, Vendargues Cedex, France 2. Direction des laboratoires et des contr?les, Agence fran?aise de sécurité sanitaire des produits de santé, Boulevard Anatole France, 143-147, 93285, Saint-Denis, France 3. Laboratoire national de contr?le de qualité des médicaments et d’expertise, BP-12216, Yaoundé, Cameroon 4. Agence du médicament de Madagascar-BP, BP-8145, 101, Antanarivo, Madagascar 5. Laboratoire national de santé, BPE-4559, Bamako, Mali 6. Laboratoire national de contr?le de qualité des médicaments, BP-6206, Rabat, Morocco 7. Laboratoire national de santé publique et d’expertise, BP-10465, Niamey, Niger 8. Laboratoire national de contr?le de qualité des médicaments, BP-6303, Dakar, Senegal 9. Laboratoire national de contr?le de qualité des médicaments, Bab Saadoun, 1006, Tunis, Tunisia |
| Abstract: | The fixed-dose combination artesunate (AS)–amodiaquine (AQ) is one of the most widely used treatments for uncomplicated falciparum malaria. It is currently proposed to the inclusion in the model list of essential medicines of World Health Organization and has been recently prequalified. Until now, no satisfactory method for the simultaneous determination of the two active ingredients had been available. Thus, a reversed phase high performance liquid chromatography for the quantitative determination of AQ and AS was developed and validated. Chromatography was performed using an end-capped octadecylsilyl silica gel column (100?×?4.6?mm, 3?μm) with a binary gradient using aqueous phase containing potassium dihydrogen phosphate (10?mM) and acetonitrile. Taking into consideration the physico-chemical characteristics of the two compounds related to their ionization, the use of a counter ion was necessary to ensure the retention of AQ in a reversed phase system simultaneously to AS. Thus, aqueous mobile phase was adjusted to pH 3.0 and the chosen counter ion was sodium 1-octanesulfonate (100?mM). In these conditions, the retention times were about 4?min for AQ and 10?min for AS with UV detection at 300 and 210?nm, respectively. Method was then validated according to ICH guideline (specificity/linearity/accuracy/precision) and potential interferences with excipients and degradation products were checked. It has also been used for an interlaboratory study involving seven African National Quality Control Laboratories and Afssaps (Agence fran?aise de sécurité sanitaire des produits de santé) laboratory. The results demonstrate that this rapid and simple method can be easily used by official laboratories for routine control, market survey and for the detection of potential substandard medicines which are very frequent in African countries. |
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