Novel Spectrophotometric Method Development for the Estimation of Boceprevir in Bulk and in Pharmaceutical Formulations

Boceprevir (Victrelis™) is indicated for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy 1-3. The literature survey showed the different studies which were carried out on Boceprevir include - Intracellular and plasma pharmacokinetics of Boceprevir, High performance liquid chromatography using UV detection for the simultaneous quantification of Boceprevir and 4 protease inhibitors in human plasma and LC-MS/MS determination of Boceprevir in rat plasma.11-12 Extractive spectrophotometry is the method of analysis for Boceprevir which involves the formation of colored ion-association complexes. The various methods proposed are described in the Table I. The optimum conditions in these methods were fixed based on the study of the effects of various parameters such as type and concentration of buffer, concentration of dye, choice of organic solvent, effect of pH on color development, ratio of aqueous to organic phase, shaking time and intensity as well as stability of the colored species in organic phase after final dilution and by measuring the absorbance at 415 nm. A. D'Avolio,A. Ciancio, M. Siccardi, L. Baietto, M. Simiele, G. Cariti, A. Calcagno, A. Smedile, J. Cusato, S. Bonora, M. Rizzetto, G. Di Perri, Ribavirinpharmacokinetics and interleukin 28B plus cytochrome P450 27B1 single-nucleotide polymorphisms as predictors of response to pegylated interferon/ribavirin treatment in patients infected with hepatitis C virus genotype 1/4, Hepatology (54); 2011: 2278-2279.