Analytical Methods for the Quantification of Ribavirin in Pharmaceutical Preparations, A Comparative Study

Abstract

Ribavirin is a broad-spectrum antiviral drug and is used to treat diseases caused by many viral infections. In this study, high-pressure liquid chromatographic and UV-Vis spectrophotometric methods were developed, validated and statistically compared to determine the amount of ribavirin in pharmaceutical preparations. HPLC analyses were performed by UV detection at 207 nm using a mobile phase consisting of 20mm KH2P04 with a flow rate of 0.8 mL min-1 on a C18 column. Ultrapure water was used as a solvent in spectrophotometric analyses. The UV spectrum of the standard and sample solutions was recorded between 200 and 400 nm and absorbance values were measured at 207 nm. Both methods were validated according to the procedures described in ICH guidelines Q2(R1) for verification of analytical methods. The results showed that spectrophotometric and liquid chromatographic methods were linear, precise, accurate, rugged, and robust with RSD values less than 1.00%, and the recovery percentage was within standard limits (98-102%). Then a statistical comparison of these two analytical methods was performed, and the results showed no significant difference. As a result, the developed analytical methods were determined to be accurate, highly effective, reliable, fast, simple, and could be used for routine quality control analysis of ribavirin in pharmaceutical formulations.