Abstract

APPLICATION OF AQBD IN CHEMOMETRIC ASSISTED METHOD DEVELOPMENT OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE BY UV-VIS SPECTROPHOTOMETRY

Shubhangi Jadhav, Rutuja Jagtap and G. K. Dyade

ABSTRACT

Quality by design is applied for the development of various pharmaceutical processes including analytical methods. By applying AQbD approach chemometric based analytical method was developed for the estimation of Emtricitabine (ECB) and Tenofovir Disoproxil fumarate (TFR) from solid dosage form by UV-VIS spectrophotometry. Solvent 0.1 N HCl was utilised in the method and 291 nm 259 nm was the wavelength for measurement of absorbance of ECB and TFR respectively. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICHQ2 R1 regulatory guidelines. Linearity of both the drugs was ascertained over the conc range 1-16 μg/ml for ECB and 5-30 μg/ml for TFR. The accuracy was found within 99.85 – 104 % for ECB and 96.99 – 105.21 % for TFR; and the precision study was shown acceptable data as SD found 0.0966 for ECB and 0.0189 for TFR. The developed method is rigid, robust and efficient for the estimation of ECB and TFR, from the solid dosage form. AQbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage.

Keywords: AQbD, Emtricitabine, Tenofovir Disoproxil fumarate, ICH, simultaneous equation.