A Liquid Chromatography Method Development and Validation of Baloxavir in Pharmaceutical Dosage Form as Per ICH Guidelines

Abstract

A new method was established for the estimation of Baloxavir by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Baloxavir by using Platisil C18 (4.6x250mm, 5µm), mobile phase ratio was Methanol: KH2PO4 PH 2.5, Run time was found to be 10 min, and detection wavelength was 247nm. Phosphate buffer solution, by adding 0.1ml of formic acid in 1000ml water. Adjust this solution to pH 4.5 by using sodium hydroxide. The solutions were chromatographed at a constant flow rate of 1ml/min and Injection volume 20µl, the run time 10min, the linearity range was found to lie from 10µg/ml to 50µg/ml of Baloxavir. Results of %Assay for Baloxavir 99.63%, the % RSD values of Baloxavir are found to be 1.274372 indicating less than 2% precision of the method and Intermediate precision for Baloxavir found to be 1.261669.  The LOD found to be 0.67 and LOQ found to be 2.25 were found to be within limit. The results obtained on the validation parameters met ICH and USP requirements.