A novel analytical liquid chromatography–tandem mass spectrometry method for the estimation of Ribavirin in bulk and pharmaceutical formulation

Abstract

The aim of this study is to develop and validate a method that is simple, precise, sensitive, and rapid compared to using the liquid chromatography-tandem mass spectrometry method for the quantitative determination of Ribavirin (antiviral drug) in its tablet formulation. The development and validation of the method were achieved using a column (Zorbax 50 mm × 4.6 mm × 5 µm) with mobile phase ammonium formate (pH: 7.50): acetonitrile in the ratio (30:70, v/v) with the flow rate of 0.5 ml/min. The retention time for Ribavirin was 1.1 minutes with the total run time of 2.5 minutes. The linearity range for Ribavirin was from 2 to 100 ng/ml with a correlation coefficient of 0.9956. The detection and quantitation limits of Ribavirin are 0.7 and 2 ng/ml, respectively. The percentage recovery of Ribavirin ranged from 94.00% to 98.33%. The percentage relative standard deviation for intraday and interday precision results was found to be 0.67%-2.11% and 1.92%-3.11%, respectively. The new method developed for Ribavirin drug was found to be rapid, sensitive, selective, and economical. The established method was the evaluation of Ribavirin in its marketed formulation (tablet). The values obtained from the analysis were found out to be within the acceptable limits as per the International Council for Harmonisation (ICH) guidelines.