Abstract

DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR THE ESTIMATION OF RIBAVIRIN IN BULK AND TABLET DOSAGE FORM

Poonam V. Suryawanshi*, Moreshwar P. Mahajan and Sanjay D. Sawant

ABSTRACT

A new specific, simple, RP-HPLC method was developed for Ribavirin in bulk and tablet formulation. Chromatographic separation was achieved better on grace C18 (250mm x 4.6id, particle size 5um) column with mobile phase consist of methanol and water (80:20 v/v) at flow rate 0.8ml/min with maximum absorbance detected at 210nm using UV-detector. The retention time was found to be 3.61min respectively. The method was validated for accuracy, precision, linearity, LOD, LOQ, robustness. The method was found to be linear in range of 10-50ug/ml with correlation coefficient (r2)0.999. the precision was estimated by interday and intra-day precision and result were calculated as % RSD with found to be within limit. The recovery of Ribavirin was found to be 99.7-100.15. The LOD and LOQ of the method were found to be 0.26ug/ml and 0.79ug/ml. the results of the analysis have been validated statistically and by recovery studies. The proposed method validated using standard ICH guideline.

Keywords: RP-HPLC, Ribavirin, validation method development, Methanol, Water.