Abstract

A FRAMEWORK FOR THE ESTABLISHMENT OF SPECIFIC ABSORBANCE VALUES FOR QUALITATIVE AND QUANTITATIVE ANALYSIS OF MEDICINES

Danike De Villiers, Ilene Brits and Marius Brits*

ABSTRACT

The application of Ultraviolet (UV) / visible (Vis) spectrophotometricanalysis has many benefits in the quality control (QC) testing ofmedicines. Specific absorbance is the measured absorbance of asample, with a concentration of 1 % (w/v), at a specific wavelengthwhen measured through a 1.0 cm pathlength. The use of specificabsorbance values in the qualitative and quantitative analysis ofmedicines has been a standard practice employed by globalpharmacopoeial bodies. However, due to the lack of guidance for theestablishment of quality assured specific absorbance values that aresuitable for its intended use, the advantageous use thereof withincurrent Good Manufacturing Practices (cGMP) regulated environmentsare hindered. This article proposes a systematic framework asguideline for the establishment and validation of specific absorbancevalues for the QC testing (i.e. identification-, assay-, and dissolution testing) of medicines.This framework has been developed considering and applying Analytical Quality by Design(AQbD) principles. Zidovudine has been used as prototype active pharmaceutical ingredient(API) to illustrate the implementation of this new framework.

Keywords: Specific absorbance, Quality control, UV/Vis spectrophotometric analysis, Analytical Quality by Design, Zidovudine, Good Manufacturing Practices.