Degradation study of selected PDE 5 inhibitors and their marketed formulation by applying QbD approach”

Abstract

The present thesis work entitled “Degradation study of selected PDE 5 inhibitors and their marketed formulation by applying QbD approach.” is divided into core nine chapters as described below in brief. Chapter 1 describes the general introduction about on era of analytical method development by multivariate approach to improve quality for risk assessment, risk reduction and risk management. The application of multivariate approach helps in optimizing multiple factor at same time. The selected approaches for method development includes, UV-Chemometric and HPLC-Quality by design have been discussed. Chapter 2 gives the detailed information of drug profile (avanafil, vardenafil and dapoxetine hydrochloride) and review of literature for analytical methods reported in public domain for determination of avanafil, vardenafil and dapoxetine hydrochloride in bulk, formulations and application of multivariate approach. The aim of this research is to study degradation of selected PDE 5 inhibitors (avanafil and vardenafil) and their marketed formulation by applying QbD approach with extending the application of developed method for degradation study of avanafil and vardenafil.