Validação de método analítico indicativo de estabilidade para doseamento de nevirapina em matéria-prima e comprimido por cromatografia líquida de alta eficiência

Abstract

Nevirapine belongs to a class of non-nucleoside reverse transcriptase inhibitor. In Brazil, this drug is available as 200 mg tablet and 10 mg mL-1 oral suspension. In Brazilian Pharmacopoeia 5th Edition there is not a monograph related to the drug nevirapine in any of its pharmaceutical forms and there are methods with different parameters described in The United States Pharmacopeial Convention (USP 38). Therefore, the aim of this study was to evaluate and optimize a single analytical HPLC method to detect and quantify raw material and tablets containing this drug. The mobile phase consisted of acetonitrile and water at a flow rate of 1.0 mL min-1 and wavelength at 220 nm. The analytical method was validated according to the official guidelines. The linearity was obtained over the concentration range from 10 to 80 mg mL-1 (r2 = 0.9987) and analysis of variance indicated linear regression without deviation from linearity (α = 5%). Adequate results were found for repeatability, intra-day precision (< 2% RSD), accuracy and robustness. Degradation studies combined with purity of peak analysis were used to evaluate the stability-indicating capability of the method.