Analytical Quality by Design Approach for the Development of UV-Spectophotometric method in the Estimation of Tenofovir Alafenamide in bulk and its Laboratory Synthetic Mixture

Abstract

The aim of present work is to develop and validate spectrophotometric method in the estimation of tenofovir alafenamide in bulk and its laboratory synthetic mixture using Analytical Quality by Design (QbD) approach as per ICH Q8 (R2) guidelines. Variable parameters like type of sample preparation, solvent, wavelength, instrumental parameters such as slit width, scan speed and sampling interval etc. were designed into Ishikawa diagram and critical parameters were determined by observation as well as by using principal component analysis. In simple spectrophotometric method tenofovir alafenamide was estimated at 258 nm using distilled water, methanol and acetonitrile. Beer’s law was obeyed in the concentration range 2.5-25 µg/ml (r2=0.998) using distilled water, 5-30 µg/ml (r2=0.996) Using methanol and 10-50 µg/ml (r2=0.997) using acetonitrile. The proposed method was found to be accurate, precise and economical and can be applicable for routine quality control analysis tenofovir alafenamide on pharmaceutical dosage form. Implementation of QbD approach resulted in more robust methods which can produce consistent, reliable, and quality data throughout the process and also save time and money.