Awot Gebreegziabher
Ethiopian Drug Administration and Control Authority, Department of Drug Quality Control and Toxicology Laboratory, PO Box 5681, Addis Ababa, Ethiopia
Asfaw Debella
Ethiopian Health and Nutrition Research Institute, Department of Drug Research, PO Box 1242/5654, Addis Ababa, Ethiopia
Abstract
One of the components of care for people living with HIV/AIDS is the use of antiretroviral drugs (ART) and the successful outcome of these drugs requires proven quality, safety and efficacy. The quality of these drugs can be assessed by qualitative and quantitative analysis using different analytical techniques. The objective of this study is to compare the analytical results of two brands of ART drug, Lamivox-150 and Lamidine using high pressure liquid chromatography (HPLC) and UV spectroscopy in order to select a validated, simple, cost-effective and affordable analytical technique. The two brands of a lamivudine tablets were quantified against a reference standard, lamivudine with HPLC and UV spectroscopy and the results were compared. The HPLC method involves the use of methanol:acetonitrile (5:95) as a mobile phase, and octadecylsilane (C18) as a stationary phase. For UV spectroscopic analysis, complete release of the active ingredient from the tablets was achieved with 0.01N HCl using ultrasonic bath for 10 min. This is followed by subsequent quantitative determination of the released drug at maximum absorbance wavelength of 280 nm. Concentrations of lamivudine ranging from 0.2-2 mg/ml and 1.6-16 µg/m were used to construct calibration curves for HPLC and UV spectroscopic analyses, respectively. The content of lamivudine per tablet in Lamivox-150 and Lamidine was found to be in agreement with the labelled amount when analysed by both techniques (p<0.05%).
Keywords: lamivudine, HPLC, UV spectroscopy, quantitative analysis, antiretroviral drugs
Ethiopian Pharmaceutical Journal Vol. 23 2005: 23-30