Analytical methods for the quantification of ritonavir in pharmaceuticals, a comparative evaluation

Abstract

ABSTRACT. Ritonavir is an antiretroviral medication used to treat AIDS (Acquired Immune Deficiency Syndrome)/HIV (Human Immunodeficiency Virus). This article describes the development and validation of spectrophotometric and liquid chromatographic techniques for ritonavir quantification in pharmaceutical formulations. Liquid chromatographic analyzes were carried out using a C18 column and a mobile phase consisted of 20 mM KH₂PO₄ (pH = 3.0) and acetonitrile (45:55, v/v), with a flow rate of 1.2 mL min^-1 and UV detection at 235 nm. For the spectrophotometric analyses, ethanol was employed as a solvent, The UV spectra of the standard and sample solution were scanned between 200 and 800 nm, and λ_max was determined as 235 nm. Analytical techniques have been validated in accordance with the processes outlined in the ICH (International Council for Harmonization) recommendations. The results showed that the analytical procedures were linear, accurate, precise, and robust. The recovery values of the methods are within the standard norms (98-102%). Following that, a statistical comparison of analytical techniques was carried out, and the findings revealed no significant difference. Consequently, the developed analytical techniques might be used quality control analysis of ritonavir in pharmaceuticals.

KEY WORDS: Ritonavir, Analysis, Method, Validation, Spectrophotometer, HPLC

Bull. Chem. Soc. Ethiop. 2022, 36(4), 737-747.                                                               

DOI: https://dx.doi.org/10.4314/bcse.v36i4.2