Bioequivalence studies of locally manufactured analgesic (Paracod) tablet
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Date
2005-11-10
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Abstract
A reverse phase high performance liquid chromatography (HPLC) method was developed for the simultaneous determination of free codeine and paracetamol in urine. A separation was obtained with the mobile phase composition of Methanol-2.5% Glacial acetic acid (15:85, v/v) under isocratic conditions. The separation was achieved with a detector wavelength of 245nm using acetanilide as the internal standard. The proposed method was found to be linear and reproducible.
The bioequivalence of a locally manufactured analgesic tablet (PARACOD) and a reference analgesic tablet (CO-CODAMOL) was studied. The drug products met all the pharmacopoeia standards of identity, strength and purity. The relative bioavailability of paracetamol (test drug) and codeine (test drug) were respectively 94.31% and 99.46%. The drug products were bioequivalent.
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A thesis submitted to the Department of Pharmaceutical Chemistry in partial fulfillment of the requirement for the degree of Master of Science
(Pharmaceutical analysis and quality control), 2005