pH Effect on Stability and Kinetics Degradation of Nitazoxanide in Solution

Fábio Barbosa; Leonardo Capra Pezzi; Julia Sorrentino; Martin Steppe; Nadia Maria Volpato; Andreas Sebastian Loureiro Mendez

doi:10.22456/2527-2616.101465

Authors

Fábio Barbosa Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Rio Grande do Sul
Leonardo Capra Pezzi Faculdade de Farmácia - Universidade Federal do Rio Grande do Sul
Julia Sorrentino Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Rio Grande do Sul
Martin Steppe Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Rio Grande do Sul
Nadia Maria Volpato Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Rio Grande do Sul
Andreas Sebastian Loureiro Mendez Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Rio Grande do Sul

DOI:

https://doi.org/10.22456/2527-2616.101465

Keywords:

Nitazoxanide, sability, kinetic, degradation products

Abstract

Stability studies correspond to a set of tests designed to assess changes in the quality of a given drug over time and under the influence of a number of factors. Among these factors, pH plays an important role, due to the catalytic effect that hydronium and hydroxide ions can play in several reactions. In the present study, the degradation kinetics of nitazoxanide was evaluated over a wide pH range, and the main degradation product generated was identified by LC-MS/MS. Nitazoxanide showed first-order degradation kinetics in the pH range of 0.01 to 10.0 showing greater stability between pH 1.0 and 4.0. The degradation rate constant calculated for these pH was 0.0885 x 10^-2 min^-1 and 0.0689 x 10^-2 min^-1, respectively. The highest degradation rate constant value was observed at pH 10.0 (0.7418 x 10^-2 min^-1) followed by pH 0.01 (0.5882 x 10^-2 min^-1). A major degradation product (DP-1) was observed in all conditions tested. Through LC-MS/MS analysis, DP-1 was identified as a product of nitazoxanide deacetylation. The effect of pH on the stability of nitazoxanide and the kinetic data obtained contribute to a better understanding of the intrinsic stability characteristics of nitazoxanide.

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