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 newlinemarketed formulation by applying QbD approach. is divided into core nine chapters as newlinedescribed below in brief. newlineChapter 1 describes the general introduction about on era of analytical method development newlineby multivariate approach to improve quality for risk assessment, risk reduction and risk newlinemanagement. The application of multivariate approach helps in optimizing multiple factor at newlinesame time. The selected approaches for method development includes, UV-Chemometric and newlineHPLC-Quality by design have been discussed. newlineChapter 2 gives the detailed information of drug profile (avanafil, vardenafil and dapoxetine newlinehydrochloride) and review of literature for analytical methods reported in public domain for newlinedetermination of avanafil, vardenafil and dapoxetine hydrochloride in bulk, formulations and newlineapplication of multivariate approach. The aim of this research is to study degradation of newlineselected PDE 5 inhibitors (avanafil and vardenafil) and their marketed formulation by newlineapplying QbD approach with extending the application of developed method for degradation newlinestudy of avanafil and vardenafil. newlineChapter 3 is about the detailed information of materials and instruments used in study. The newlinechapter also includes identification of selected drugs avanafil, vardenafil and dapoxetine newlinehydrochloride. newlineChapter 4 describes the UV-chemometric and HPLC-quality by design methods for newlinesimultaneous estimation of avanafil and vardenafil in tablet dosage form. Chemometric newlinemethods have been developed, including classical least-squares, principal component newlineregression, partial least squares, and multiway partial least-squares. Analytical figures of newlinemerit, such as sensitivity, selectivity, analytical sensitivity, LOD, and LOQ were determined. newlineQbD consists of three steps, starting with the screening approach to determine the critical newlineprocess parameter and response variables. This is followed by understanding of factors and newlinelevels, and lastly the application of a