Boeprevir Analysis

INTRODUCTION

Boceprevir is a protease inhibitor used in treatment of hepatitis caused by hepatitis C virus (HCV) genotype 1 in combination with peginterferon and ribavirin[1,2]. Specifically, boceprevir inhibits the proteolytic cleavage of the HCV encoded polyprotein, an essential step in the viral life cycle for the production of mature forms of the viral proteins . It is marketed under the trade name Victrelis, now being developed by Merck and was approved by FDA in 2011[3].

Fig 1.: Chemical structure of Boceprevir

Literature survey reveals that very few analytical methods have been reported for Boceprevir[4].. Hence, considering inherent advantage of HPTLC over HPLC, the objective of current work was to develop SIM HPTLC method

It was observed that drug showed considerable absorbance at 215 nm. So, wavelength 215 nm was selected as the wavelength for detection.

Fig. 2: UV Spectrum of Boceprevir (100µg/ml
Analysis of Drug in blend mixture
Accurately weighed quantity of Boceprevir was mixed with blank blend containing starch and lactose. Spiked blend was assayed and used for accuracy studies. To determine accuracy, 200 mg BB and 800 mg drug were mixed properly and finally 1000 mg SB were prepared. 100 mg were then collected and tested under 80% accuracy parameter, subsequentely 100% and 120% accuracy levels were also determined. Stress degradation studies of bulk drug
The forced degradation studies were carried out on bulk drug substance in order to prove the stability-indicating property and selectivity of the developed method. The degradation was carried out under acid, base and neutral hydrolytic, Oxidative and Thermolytic
Acid treatment
5 ml working standard solution of Boceprevir (10000 µg/ml) was mixed with 5 ml of 1N methanolic hydrochloric acid (HCl) and 40 ml of methanol. Solution was reflux at 800c for 15 min. The 6 µl of resulting solution was applied on TLC plate and developed under optimized chromatographic