Development and Validation of Analytical Method of Raltegravir, An Antiviral Drug

Abstract

The stability of Raltegravir (RAL) was investigated under different stress conditions, including hydrolytic, oxidative, photolytic and thermal, as recommended by the ICH guidelines. Degradation was observed under alkaline hydrolytic condition. The major degradation products in alkaline degradation conditions were proposed. A simple, sensitive and specific HPLC method was developed for the quantification of RAL under forced degradation study. The separation employs aluminum backed silicagel-G F254 as stationary phase and mixture of Toluene: ethylacetate: methanol: acetic acid (8:1:1:0.1v/v/v/v) as a mobile phase. The detection wavelength of 299nm was selected for analysis. The method was validated, demonstrating to be accurate and precise (repeatability and intermediate precision levels) within the corresponding linear range of RAL (200-700ng/spot;r= 0.9923, n=5).Limits of detection and limit of quantification were determined to be 33.99ng/spot and 103.01ng/spot respectively. Peak purity indices (>0.9997) and satisfactory resolution between RAL and its degradation products established the specificity of the determinations. The kinetics of the degradation of RAL in alkaline medium was studied, determining as zero order kinetics with energy of activation to be 5.99 Kcal/mol.