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A titrimetric and a spectrophotometric methods are developed and validated for the assay of artesunate in pure and in tablets. The titrimetric method is based on the reaction of artesunate with acid resulting in the cleavage of the endoperoxide bond of the molecule, hence hydrogen peroxide is generated in situ; this in the presence of potassium iodide liberates iodine which is then titrated against standardized sodium thiosulphate. The spectrophotometric method is based on the opening of the lactone ring by sodium hydroxide resulting in an alkali decomposed product which absorbs light at 300nm. In the titrimetric method the percentage content of active ingredient per tablet was ≥ 99.5% ≤ 105% ±1. In the spectrophotometric method Beer’s law was obeyed in the range of 0.5μg/ml - 50μg/ml with linear regression equation of A = 0.02e and correlation coefficient of (r) 0.9998 (n = 10). The apparent molar absorptivity and Sandell sensitivity were 1.36x103.L/mol/cm and 0.282μg/cm2. The limits of detection (LOD) and quatification (LOQ) determined as per the current International Conference on Harmonization (ICH) guidelines were 0.375 and 1.25μg/ml respectively. The precision (RSD%) and accuracy (RE%) determined by evaluating the inter and intra day variations at three artesunate concentration levels were < 2.5% and < 3.0 respectively. These validated methods were successfully applied to assay tablets procured locally and the results found to be in good agreement with the reference titrimetric method in the international pharmacopoeia. The accuracy and validity of these methods were further confirmed by performing recover studies via standard addition procedure with the results showing that excepients have no effects on the methods.
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Author(s): Attih E E Udobang J A Ambe D A and Akpan A
Artesunate, Assay, Endoperoxide Bond Spectrophotometric, and Titrimetric, Rapid titrimetric and spectrophotometric methods