Design of simple UV spectrophotometric and HPLC methods for assay of artesunate and amodiaquine in fixed dose tablet formulations.

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2014-11-24
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Artesunate and Amodiaquine combination is one of the first line drugs for the treatment of uncomplicated malaria. To prevent treatment failures and emergence of resistant strains of the Plasmodium parasite, patients are entreated to comply with treatment regimens. Thus fixed dose tablet formulations came as a relieve to patients, ensuring proper compliance as the number of tablets to be taken was reduced. It is therefore important to develop simple methods of assay for these formulations to ensure that quality drugs are available and to prevent resistance to these drugs. This thesis describes Ultraviolet (UV) and High Performance Liquid Chromatographic (HPLC) methods of assay for Artesunate(AS) and Amodiaduine Hydrochloride(AMQ) in fixed dose tablet formulations. The UV absorption spectroscopy was used to establish a wavelength of maximum absorption and the Beer’s plot generated. At 339nm, Amodiaquine Hydrochloride was assayed accurately in methanol with a high r2 value of 0.998, an intra and inter day precision of Relative Standard Deviation (RSD) of 1.52% and 1.86% respectively. The Beer’s plot was obeyed in a concentration range of 3.5 - 24.8(µg/mL). The limit of detection and limit of quantification was 1.23(µg/mL) and 3.73(µg/mL) respectively. However the UV method could not be used to assay AS simultaneously with AMQ. A mobile phase of 60% acetonitrile and 40% of 0.05% trifluoroacetic acid, flow rate of 1ml/min, wavelength of detection of 225nm and a C18 stationary phase are the parameters for the HPLC method. The r2 for the HPLC method was 0.996 and 0.995 for Amodiaquine hydrochloride and Artesunate respectively. The intra and inter day precision were 1.07% and 1.42% respectively. The limit of detection and limit of quantification were 0.015%w/v and 0.0465%w/v for Amodiaquine hydrochloride and 0.054%w/v and 0.019%w/v for Artesunate respectively. The concentration ranges were 0.01- 0.16%w/v for Amodiaquine hydrochloride and 0.01 – 0.2%w/v for Artesunate. The methods were used to assay three brands of tablet formulations in the Kumasi metropolis. The percentage content of Artesunate: Amodiaquine hydrochloride were 103.87:95.85, 97.04:110.02 and 109.32:101.34 for brand A, B and C respectively.
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A thesis submitted in partial fufilment of the requirement of the degree of Master of Philosophy in Pharmaceutical Chemistry
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