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Please use this identifier to cite or link to this item: http://hdl.handle.net/123456789/9038

Title: The use of surrogate reference standards in quantitative rp-hplc for the analysis of multicompnent formulations: a case of Artemether and Lumefantrine
Authors: Appiah, Enoch
Issue Date: 3-Oct-2016
Abstract: A simple, rapid isocratic RP-HPLC method was developed for the quantitative analysis of Artemether and Lumefantrine using Diclofenac and Ibuprofen as surrogate reference standards. The assay of Artemether and Lumefantrine was done by the use of a surrogate constant calculated for each surrogate in relation to the particular analyte of interest. The analysis was performed on a Kromasil C-18 (4.6 x 250 mm) 5µm column using a mobile phase composition of methanol and acetate buffer (pH 2.8) in a ratio of 85:15 (v/v). An isocratic mode of elution was employed using a flow rate of 1 ml/min and a UV wavelength of detection at 230 nm. The mean retention times in minutes obtained for Diclofenac, Ibuprofen, Artemether and Lumefantrine were 4.60 ± 0.031, 5.08 ± 0.017,7.48 ± 0.056 and 8.63 ± 0.028 minutes respectively. The surrogate constant obtained for Diclofenac and Ibuprofen when used as surrogate for Artemether were 0.007637 ± 0.00045 and 0.02477 ± 0.00074 respectively. The surrogate constant obtained for Diclofenac and Ibuprofen when used as surrogate for Lumefantrine were 2.919989 ± 0.1847 and 10.513 ± 0.3051 respectively. The effect of concentration on the surrogate constant was investigated and concentration ratio limits were specified for each surrogate. Percentage contents obtained for the four commercial brands of tablets AL 1, AL 2, AL 3 and AL 4 using Diclofenac as surrogate for Artemether were 96.76 ± 0.7132, 97.92 ± 0.7186, 98.16 ± 0.6411 and 96.26 ± 0.9900 respectively while percentage contents of 105.47 ± 0.6044, 103.45 ± 0.8272, 102.62 ± 0.6251 and 104.77 ± 0.3760 respectively were obtained for Lumefantrine using the same surrogate. Percentage contents obtained for the four commercial brands AL 1, AL 2, AL 3 and AL 4 using Ibuprofen as surrogate for Artemether were 98.81 ± 0.9661, 97.83 ± 0.6382, 98.64 ± 1.2596 and 97.03 ± 0.5989 respectively while percentage contents of 104.12 ± 0.8054, 102.42 ± 0.9090, 101.99 ± 0.4496 and 103.79 ± 0.5443 respectively were obtained for Lumefantrine using the same surrogate. The method was validated in accordance to the ICH guidelines and was shown to have acceptable levels of accuracy, precision, robustness, linearity over the given concentration range and sensitivity for Artemether and Lumefantrine using Diclofenac and Ibuprofen as surrogate reference standards. The results obtained for the assay of Artemether/Lumefantrine tablets using the developed method showed no statistical difference when compared to results obtained for the same brands assayed with the standard method in the International Pharmacopeia.
Description: Dissertation submitted to the Department of Pharmaceutical Chemistry of the faculty of Pharmacy and Pharmaceutical Sciences, KNUST in partial fulfilment of the requirements for the award of Master of Philosophy degree in Pharmaceutical Chemistry, 2016.
URI: http://hdl.handle.net/123456789/9038
Appears in Collections:College of Health Sciences

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