Spectrophotometric Method for Determination of Oseltamivir in Capsule Dosage Form

Objectives: Study was aimed to establish and vindicate a simple, accurate and precise spectrophotometric method for the quantification of oseltamivir in API and capsule dosage form. Materials and Methods: The green coloured chromogen complex absorbance which was formed by the oxidative coupling with loss of two electrons and a proton of oseltamivir with MBTH in presence of FeCl3 was measured at 640nm. The amount of oseltamivir labelled in the marketed formulation (Fluvir) was determined without any interference owed with excipients. Results: A correlation coefficient of 0.999 was observed within the concentration range of 10-110μg/mL. The method was aided by various validation parameters such as LOD, LOQ and percentage relative standard deviation values (3.75 μg/mL, 9.86 μg/mL and 0.999 respectively). The percentage assay in capsule dosage form was found to be 97.6, which in conformance with ICH guidelines. Conclusion: Results were found to be within the permissible limits. Present method was verified statistically in consonance with ICH Q2R (1) guidelines. Based on above remarks, developed method may be successfully employed in regular analysis of oseltamivir in various pharmaceutical dosage forms.