RP-HPLC Method for Estimation of Zanamivir in API and Pharmaceutical Formulation

Abstract

The present work aimed to develop a new simple, accurate and reproducible RP-HPLC method for the analysis of Zanamivir. The method was validated according to ICH (Q2R1) guidelines. The chromatographic conditions were effectively monitored for the elution of analyte utilizing YMC C18 column (4.6 × 150 mm, 5µ); water: methanol (20:80 % v/v) as a solvent system with a 0.6 mL/min of flow at detection wavelength of 320 nm. The retention of analyte was achieved at 2.497 minutes. The tablet sample was assayed with 99.52 %±0.425 purity. The system suitability parameters such as plate count and tailing factor were found to be 4159.0 and 1.5, respectively. The linearity of the method achieved at the concentration range of 20-100 µg/mL with a correlation coefficient (r2) of 0.998. The accuracy study showed 99.95%±0.126 of recovery of analyte. Precision in terms of repeatability was found within the limit (% RSD-0.159), while intermediate precision was shown % RSD of 0.15. LOD and LOQ were predicted at 3.04 and 10.14 µg/mL, respectively. In addition, the method found robust at a deliberate change of flow rate and solvent composition. Therefore, the results confirmed the suitability of the method for quantifying Zanamivir in their formulations.