Abstract

In the development strategies of new drug products and generic drug products, the simultaneous in-vitro dissolution behavior of oral dosage formulations is the most important indication for the quantitative estimation of efficiency and biopharmaceutical characteristics of drug substances. This is to force the related field's scientists to improve very powerful analytical methods to get more reliable, precise and accurate results in the quantitative analysis and dissolution testing of drug formulations. In this context, two new chemometric tools, partial least squares (PLS) and principal component regression (PCR) were improved for the simultaneous quantitative estimation and dissolution testing of zidovudine (ZID) and lamivudine (LAM) in a tablet dosage form. The results obtained in this study strongly encourage us to use them for the quality control, the routine analysis and the dissolution test of the marketing tablets containing ZID and LAM drugs.

Highlights

  • Zidovudine (ZID) or azidothymidine (AZT) has been used for the treatment of human immunodeficiency viruses (HIVs)/AIDS infectiousness

  • In order to solve this problem we focused mainly on the application of partial least squares (PLS) and principal component regression (PCR) calibration methods for the simultaneous quantification and dissolution testing of ZID and LAM

  • The building PLS and PCR calibration models were used to quantify the concentration of each active compound in commercial tablet, dissolution samples and other samples

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Summary

Introduction

Zidovudine (ZID) or azidothymidine (AZT) has been used for the treatment of HIV/AIDS infectiousness. ZID triphosphate is inhibition of reverse transcriptase via DNA chain termination after incorporation of the nucleoside analogue. The principal mode of action of LAM triphosphate is inhibition of reverse transcriptase via DNA chain termination after incorporation of the nucleoside analogue. In the work presented in this study, two different chemometric calibration approaches, PLS and PCR were applied for the quantification and dissolution testing of ZID and LAM in commercial tablets. The validity or ability of the applied PLS and PCR calibration methods were performed by analyzing the test samples of the related drugs. The applied PLS and PCR calibration models were used for the quantification and dissolution tests of the commercial samples containing ZID and LAM substances

Experimental
4. Chemometric Methods
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