Abstract

The intent of this study is to develop and validate a method which is simple, precise, sensitive and rapid using LC-MS/MS method for quantitative determination of Ribavirin (anti-viral drug) in its tablet formulation. The method development and validation was achieved using column (Zorbax 50 mm×4.6 mm×5µm) 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 min with the total run time of 2.5 min. The linearity range for Ribavirin was from 2 ng/ml to 100 ng/ml with correlation coefficient 0.9956. Detection limit and quantitation limit of Ribavirin includes 0.7 ng/ml and 2 ng/ml, respectively. The percentage recovery of Ribavirin ranged from 94.00 - 98.33 %. The percentage relative standard deviation for intra-day and inter-day 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 evaluation of Ribavirin in its marketed formulation (tablet). The values obtained from the analysis were found out to be within acceptance limits as per the ICH guidelines.

Key words: Ribavirin; Formulation; LC-MS/MS; Validation; ICH