Design of a suitable HPLC method of analysis for artesunate /amodiaquine fixed dose combination drug
Loading...
Date
2005-11-03
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
The anti-malarial drug policy for Ghana has adopted Artesunate/Amodiaquine as a first line drug for the treatment of uncomplicated malaria. At present there is no existing method for the analysis of the active ingredients present in this combination drug in the official compendia. And much as the quality of this combination drug therapy cannot be overlooked, a suitable HPLC method of analysis for the active ingredients present in the combination drug therapy was developed and validated. Two different mobile phase composition systems comprising of, Methanol/Phosphate buffer in the ratio 90: 10 and, Methanol / Water containing 0.lml of acetic acid (90:10) in isocratic mode of elution were all capable of separating the solutes of interest with good resolution and appreciable retention times. Two commercial products, Amotex 1000 (from Kinapharma Ltd. Accra) and Biosunate (from Pam Pharmaceuticals, and manufactured for BRI (GH) Ltd) were used to validate the method. In consequence, statistical evaluations at the 95% confidence limits revealed that the method was reliable, less time consuming, selective and more economical. With an instrument precision of 0.99% RSD, the relative error of the mean was found to be ±0.104. The two tailed (F-test) also revealed an insignificant difference in the range of concentration of Artesunate when analyzed alone and when in combination with Amodiaquine. Also evidence of correlation at the 95% confidence level between the new HPLC method developed and the official International Pharmacopoeia for the assay of Artesunate and Amodiaquine showed no significant difference in the means of the HPLC , UV, and Titrimetric methods. However, at the same 95% confidence level the HPLC method has a better precision than the UV method for the analysis of Amodiaquine (Refer subsection 3.6.6d). Ibuprofen was used as the internal standard.
Description
A thesis submitted to the College of Health Sciences in partial fulfilment of the requirements of the award for the degree of Master of Science, 2005