A comparative study of HPLC and UV spectrophotometric methods for oseltamivir quantification in pharmaceutical formulations

This paper presents a comparative study on the development and validation of High-Performance Liquid Chromatography (HPLC) and Ultraviolet (UV) spectrophotometric methods for the quantitative determination of oseltamivir in pharmaceutical formulations. The primary purpose was to establish reliable, accurate, and precise analytical methods for quality control of this antiviral drug, particularly relevant during the COVID-19 pandemic. Both methods were developed and validated according to ICH guidelines, assessing parameters such as selectivity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness. The HPLC method utilized a C18 column with a mobile phase of potassium dihydrogen phosphate solution and acetonitrile (60:40, v/v) at a flow rate of 1.2 mL min−1, detecting oseltamivir at 215 nm. The UV method also used a wavelength of 215 nm with methanol as the solvent. Both techniques demonstrated excellent linearity (correlation coefficients > 0.999 within 10–60 μg mL−1), high accuracy (LC: 99.85–100.17%; UV: 99.26–100.70%), and good precision, with no interference from capsule excipients. The study concluded that both methods provide reliable outcomes for oseltamivir quantification in pharmaceutical preparations.

This paper presents a comparative study on the development and validation of High-Performance Liquid Chromatography (HPLC) and Ultraviolet (UV) spectrophotometric methods for the quantitative determination of oseltamivir in pharmaceutical formulations. The primary purpose was to establish reliable, accurate, and precise analytical methods for quality control of this antiviral drug, particularly relevant during the COVID-19 pandemic. Both methods were developed and validated according to ICH guidelines, assessing parameters such as selectivity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness. The HPLC method utilized a C18 column with a mobile phase of potassium dihydrogen phosphate solution and acetonitrile (60:40, v/v) at a flow rate of 1.2 mL min−1, detecting oseltamivir at 215 nm. The UV method also used a wavelength of 215 nm with methanol as the solvent. Both techniques demonstrated excellent linearity (correlation coefficients 0.999 within 10–60 μg mL−1), high accuracy (LC: 99.85–100.17%; UV: 99.26–100.70%), and good precision, with no interference from capsule excipients. The study concluded that both methods provide reliable outcomes for oseltamivir quantification in pharmaceutical preparations. Research Background and Significance Oseltamivir phosphate is a widely used antiviral agent, notably employed in the treatment and prevention of influenza and other viral respiratory infections. The emergence of the COVID-19 pandemic has underscored the critical importance of reliable analytical techniques for quantifying active pharmaceutical ingredients (APIs) in drug formulations, ensuring efficacy and safety. Accurate measurement of oseltamivir content in pharmaceutical products is essential for quality control