Development & Validation of RP-HPLC Method for the Determination of Oseltamivir Phosphate API

A simple and rapid liquid chromatographic assay for the evaluation of potentially counterfeit oseltamivir phosphate has been developed and assessed. The present study describes the development of a new, simple, reproducible RP-HPLC method for the quantitative determination of Oseltamivir phosphate (OSP). The proposed method utilizes C-18 column 100mm x 4.6mm at 25◦C with isocratic run using Methanol and Acetonitrile (50:50 v/v) at a flow rate of 1ml/min. and UV detection at 227 nm. The method was statistically validated for linearity, ruggedness, robustness, precision, and accuracy. The calibration curve was obtained in the concentration range of 5-35μg/ml with correlation coefficient 0.996. The robustness of the method has been studied by slightly varying the chromatographic conditions.