Abstract

METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE QUANTIFICATION OF OSELTAMIVIR PHOSPHATE IN PHARMACEUTICAL DOSAGE FORMS

K. Aneela*, T. Arun Kumar, K. Sravan Kumar, B. Pravachana, S. D. Samreen, Ch. Asha

ABSTRACT

A simple, precise, accurate, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative determination of oseltamivir phosphate in pharmaceutical dosage forms. Chromatographic separation was achieved using a suitable C18 column with an optimized mobile phase consisting of a mixture of buffer and organic solvent in an appropriate ratio, delivered at a constant flow rate. Detection was carried out using a UV detector at a selected wavelength where the drug exhibits maximum absorbance. The developed method was validated according to ICH guidelines for parameters such as linearity, accuracy, precision, specificity, robustness, and limit of detection (LOD) and limit of quantification (LOQ). The method showed good linearity over a suitable concentration range with a high correlation coefficient. Accuracy was confirmed by recovery studies, and precision was demonstrated through repeatability and intermediate precision studies with low %RSD values. The method was found to be specific, with no interference from excipients present in the formulation. The validated RP-HPLC method was successfully applied for the routine analysis of oseltamivir phosphate in pharmaceutical dosage forms, proving to be reliable, efficient, and suitable for quality control purposes.

Keywords: RP-HPLC, Oseltamivir phosphate, Method development, Method validation, Quantitative analysis, Pharmaceutical dosage forms, ICH guidelines, Quality control.