Development and validation of UV Spectrophotometric Method for Estimation of Rilpivirine Hydrochloride in Bulk and Pharmaceutical Formulations

摘要

  ABSTRACT A simple, rapid, precise, and economical spectrophotometric method has been developed for quantitative analysis of Rilpivirine hydrochloride (RILH) in manufactured tablet formulations. The initial stock solution of RILH was prepared in dimethyl formamide: acetonitrile solvent and subsequent dilution were done in acetonitrile. The standard solution of RILH in acetonitrile showed absorption maxima at 281.6 nm. The drug obeyed Beer–Lambert’s law in the concentration range of 1–16 μg/mL with coefficient of correlation (R2) was 0.9999. It showed coefficient of variation below 2 % in intra-run and inter-run precision.  The results of analysis have been validated as per ICH guidelines. The method can be adopted in routine analysis of RILH in bulk and tablet dosage form and it involves relatively low cost solvents and no complex extraction techniques. Keywords: ICH guidelines, Method validation, Rilpivirine Hydrochloride, UV Spectrophotometric