Development and Validation of an RP-HPLC Assay for the Quantitative Analysis of Oseltamivir Phosphate in Bulk and Formulated Capsules

Abstract

Oseltamivir phosphate (OP), an inhibitor of the neuraminidase enzyme, is essential for treating Influenza A, B, and COVID-19. This study focuses on the synthesis of OP and the development and validation of an RP-HPLC method for determining its concentration. Through a Michael addition reaction with pyrimidine as a catalyst, OP was successfully synthesised with an 85 percent practical yield. Using a C18 Agilent Zorbax Bonus-RP column (240 mm x 4.6 mm, 5 m) at an oven temperature of 30°C and a mobile phase consisting of 0.1 percent trifluoroacetic acid (TFA) in water and acetonitrile (ACN) (65:35 v/v), the drug and capsule formulation were separated chromatographically. At a flow rate of 1 mL/min, 10 L was injected into the RP-HPLC apparatus, and peaks were identified at 218 nm. The retention time (RT) of the developed method was 2.53 minutes, with a linear calibration curve (R2 = 0.9999).This technique of synthesis is straightforward and effective, with the catalyst producing great results in practise. In addition, the RP-HPLC method for OP measurement was accurate, precise, and cost-effective. Consequently, RP-HPLC can be utilised for routine quantitative evaluations of pharmaceuticals and formulations. This research contributes significantly to the field of pharmaceutical analysis and quality control