RP-HPLC-UV method validation for Ribavirin used in topical applications

In this research paper, accurate, cost effective and a straightforward reverse phase- High Performance Liquid Chromatography process was established and verified for the estimation of Ribavirin in topical dosage form. Chromatography separation technique was done on USP L17 (4.6mm×15cm) column possessing particles size of 5µm with liquid mobile phase consisting of sulfuric acid to a pH of 2.5±0.1 having column temperature 65±0.5ºC. Flow rate was kept 1mL per min. Estimation of ribavirin was done at 207nm with the help of UV-detector. Linearity was performed for Ribavirin and calibration curve was obtained which is linear for which is well within the limit. The method is developed & verified for accuracy, precision, linearity, range, specificity, and limit of detection (LOD), limit of quantization (LOQ), ruggedness & robustness. A simple, green, cost & time effective, robust and precise HPLC procedure for estimation of ribavirin was established. This procedure was then verified according to ICH guidelines Q2 (R1) Validation of Analytical methods. Ribavirin was determined accurately and precisely in topical dosage form. Overall this method was developed and performed for the determination of ribavirin amount in any dosage form within 2 minutes in a precise and accurate way.