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 tousing 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 (3070,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 of2.5 minutes. The linearity range for Ribavirin was from 2 to 100 ng/ml with a correlation coefficient of 0.9956. Thedetection and quantitation limits of Ribavirin are 0.7 and 2 ng/ml, respectively. The percentage recovery of Ribavirinranged from 94.00% to 98.33%. The percentage relative standard deviation for intraday and interday precision resultswas found to be 0.67%–2.11% and 1.92%–3.11%, respectively. The new method developed for Ribavirin drug wasfound to be rapid, sensitive, selective, and economical. The established method was the evaluation of Ribavirin in itsmarketed formulation (tablet). The values obtained from the analysis were found out to be within the acceptable limitsas per the International Council for Harmonisation (ICH) guidelines.