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Background: To check the widespread manufacture and distribution of counterfeit Artemisinin derivatives in Nigeria, a simple sensitive spectrophotometric method has been developed.
Method: The method was based on the nucleophilic reaction of Artesunate (ART) and Dihydroartemisinin (DHA) with Anisaldehyde/Sulphuric acid reagent, monitored spectrometrically at ?max500nm and 490nm for ART and DHA respectively.
Results: Beers Law was obeyed within the range of 5.0 - 50µg/ml and 5.5 - 60µg/ml for ART and DHA respectively. The linear calibration curve determined through the least square method had regession equation of A= mx + c with the correlation coefficient of 0.996 and 0.9980 for ART and DHA respectively. Sensitivity parameters – Molar Absorptivity and Sandell Sensitivity were determined with the value 2.28×104 and 2.25 ×104, and 0.83 and 0.59 µg/cm2 for ART and DHA respectively. Limits of Detection (LVD) and Qualification (LOQ) determined as per the current international committee on Harmonization (ICH) were found to be 0.37 and 0.30 for ART and DHA respectively. The inter-day and intraday precision and accuracy were ? 2.9. The method was used to assay commercial tablets produced for local Pharmacies in Uyo, Nigeria, and was statistically compared with an official method via student T test and various F tests.
Conclusion: A simple, sensitive and reproducible method based on the nucleophilic reaction of the drugs with Anisaldehyde/Sulphuric acid has been developed for the determination of ART and DHA in tablets distributed in local pharmacies in Uyo metropolis.
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