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

Tabassum Bano; Rupesh Dudhe; Nitin Kumar

Tabassum Bano Oxford College of Pharmacy, Massorie Industrial Area, UPSIDC, MG Road, Ghaziabad., U. P., 201001, India.
Rupesh Dudhe Department of Pharmacy, Galgotias University, Yamuna Expressway, Greater Noida,U. P., 201306, India
Nitin Kumar Oxford College of Pharmacy, Massorie Industrial Area, UPSIDC, MG Road, Ghaziabad., U. P., 201001, India.

Keywords: Oseltamivir phosphate (OSP), RP-HPLC.

Abstract

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 5-35?g/ml with correlation coefficient 0.996. The robustness of the method has been studied by slightly varying the chromatographic conditions.

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