Development and validation of UV spectrophotometric method for the determination of artesunate and dihydroartemisinin by coupling
Emmanuel Etim, Aniefiok Udobre, Ekarika Johnson, Anwanabasi Udoh and Etienne Essien
There is high rate of malaria treatment failure mostly due to the abundance of fake and substandard artesunate and dihydroartemisinin. Most of the instrument available for the determination of these products in pharmaceutical formulations are very sophisticated and expensive and occasionally nonexistence in most third world countries where malaria is endemic. The drug does not have a chromophore for easy UV analysis. We developed and validated a simple and reproducible ultraviolet spectrophotometric method that could be used to analyse artesunate and dihydroartemisinin in bulk and pharmaceutical formulations by coupling the drug with freshly prepared benzene diazonium chloride. The method was validated for linearity, accuracy, precision, reproducibility and specificity as stated in the International Conference on Harmonization (ICH) guidelines. It was also used to determine the content in two brands each of artesunate and dihydroartemisinin in Uyo metropolis, and the results agreed with that on the label. A calibration graph of coupled artesnate (ART) had a standard deviation of 0.0551 while that of dihydroartemisinin (DHA) was 0.0631. The regression data for the calibration graph showed a good linear relationship (r=0.9971) over a concentration range of 2.0 - 10.0μg/ml using linear regression equation y = 0.075x + 0.018. The Limit of detection (LOD) were found to be 0.2451μg/ml for ART and 0.3009μg/ml for DHA, while limit of quantification (LOQ) were 0.7424μg/ml for ART and 0.9118μg/ml for DHA respectively. The Coefficient of Variation (CV) for both intra-day and inter-day accuracy expressed as percentage relative error was <2.8. Recovery studies using standard addition methods showed no interference with common excipients. The proposed method gave good validation results and statistical analysis proved that the method is precise, accurate and reproducible and could be used for routine analysis.
How to cite this article:
Emmanuel Etim, Aniefiok Udobre, Ekarika Johnson, Anwanabasi Udoh, Etienne Essien. Development and validation of UV spectrophotometric method for the determination of artesunate and dihydroartemisinin by coupling. Pharma Innovation 2016;5(8):04-07.