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

This paper describes the development and validation of a novel reversed-phase high-performance liquid chromatography (RP-HPLC) method for the accurate and reproducible quantification of Zanamivir, an antiviral drug, in both its active pharmaceutical ingredient (API) form and pharmaceutical formulations. The method was developed and validated in accordance with ICH Q2R1 guidelines, ensuring its suitability for regulatory purposes. The chromatographic separation was achieved using a YMC C18 column (4.6 × 150 mm, 5µ) with an isocratic mobile phase consisting of water and methanol (20:80 % v/v) at a flow rate of 0.6 mL/min. Detection was performed at 320 nm, and Zanamivir eluted at 2.497 minutes. The method demonstrated excellent linearity over a concentration range of 20-100 µg/mL with a correlation coefficient (r2) of 0.998. High accuracy was observed with a recovery of 99.95% ± 0.126, and precision was confirmed by low relative standard deviation values for repeatability (0.159%) and intermediate precision (0.15%). The limits of detection (LOD) and quantification (LOQ) were determined to be 3.04 µg/mL and 10.14 µg/mL, respectively, indicating high sensitivity. Furthermore, the method exhibited robustness against minor changes in flow rate and mobile phase composition, making it suitable for routine quality control analysis of Zanamivir.

This paper describes the development and validation of a novel reversed-phase high-performance liquid chromatography (RP-HPLC) method for the accurate and reproducible quantification of Zanamivir, an antiviral drug, in both its active pharmaceutical ingredient (API) form and pharmaceutical formulations. The method was developed and validated in accordance with ICH Q2R1 guidelines, ensuring its suitability for regulatory purposes. The chromatographic separation was achieved using a YMC C18 column (4.6 × 150 mm, 5µ) with an isocratic mobile phase consisting of water and methanol (20:80 % v/v) at a flow rate of 0.6 mL/min. Detection was performed at 320 nm, and Zanamivir eluted at 2.497 minutes. The method demonstrated excellent linearity over a concentration range of 20-100 µg/mL with a correlation coefficient (r2) of 0.998. High accuracy was observed with a recovery of 99.95% ± 0.126, and precision was confirmed by low relative standard deviation values for repeatability (0.159%) and intermediate precision (0.15%). The limits of detection (LOD) and quantification (LOQ) were determined to be 3.04 µg/mL and 10.14 µg/mL, respectively, indicating high sensitivity. Furthermore, the method exhibited robustness against minor changes in flow rate and mobile phase composition, making it suitable for routine quality control analysis of Zanamivir. Research Background and Significance Zanamivir is a neuraminidase inhibitor primarily used as an antiviral agent for the treatment and prevention of influenza virus infections. Accurate quantification of Zanamivir in its active pharmaceutical ingredient (API) form and formulated products is essential for ensuring drug efficacy, safety, and regulatory compliance. Despite its clinical importance, there has been limited availability of rapid