Chemometrics - Assisted Determination of Emtricitabine and Tenofovir Disoproxil Fumarate Combination in Commercial Tablets
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Date
2008-06
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Addis Ababa Universty
Abstract
In this thesis, derivative spectrophotometric and multivariate method of assaying truvada®
combination tablets, which contain tenofovir disoproxil fumarate 300 mg, and emtricitabine 200
mg, is described. Emtricitabine, 4-amino-5-fluoro-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-
pyrimidin-2-one, and tenofovir DF, 1-(6-aminopurin-9-yl)propan-2-yloxymethylphosphonic
acid, are anti-HIV drugs of nucleoside / nucleotide reveres transcriptase inhibitor class.
Emtricitabine was determined at 294.5 nm using the "zero crossing" technique because the
signals of tenofovir DF is zero at this wavelength. Tenofovir DF was determined at 270.5 nm by
the same technique because emtricitabine have no contribution at this wavelength. Tenofovir DF
was quantified at 249.5nm and 270.5 nm wavelengths by using derivative ratio technique
because the signal of emtricitabine was zero at these wavelengths. Emtricitabine was quantified
at 288.5 and 303.5 nm because the signal of tenofovir DF was zero at these wavelengths. By
classical least square (CLS) and principal component regression (PCR) methods good
reproducible and repeatable results were obtained. In choosing the optimal magnitudes for the
simultaneous determination of both drugs, the following criteria were considered: the linearity,
the intercept, the sensitivity, the degree of interference, the relative percent error, the relative
recovery, and the reproducibility. The R2 values which are in excess of 0.999, which indicated
the good linearity of the calibration graphs. Sample recovery rates were found satisfactory
(almost all are > 99%) with relative standard deviations (RSD) of less than 5%. The mentioned
chemometrics-assisted techniques were successfully applied to simultaneous determination of
emtricitabine and tenofovir DF in the laboratory-prepared mixtures and commercial tablets with
considerable precision and good recoveries.
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Keywords
Tenofovir disoproxil fumarate