Drilling into “Quality by Design” approach for analytical methods

L Chiarentin, C Gonçalves, C Augusto… - Critical Reviews in …, 2023 - Taylor & Francis
The need for consistency in analytical method development reinforces the dependence of
pharmaceutical product development and manufacturing on robust analytical data. The …

Application of the Quality by Design Concept (QbD) in the Development of Hydrogel-Based Drug Delivery Systems

SF Mohseni-Motlagh, R Dolatabadi, M Baniassadi… - Polymers, 2023 - mdpi.com
Hydrogel-based drug delivery systems are of interest to researchers for many reasons, such
as biocompatibility, high diversity, and the possibility of administration from different routes …

HPLC determination of colistin in human urine using alkaline mobile phase combined with post-column derivatization: Validation using accuracy profiles

K Papavasileiou, A Tsiasioti, PD Tzanavaras… - Molecules, 2022 - mdpi.com
In this study, the development, validation, and application of a new liquid chromatography
post-column derivatization method for the determination of Colistin in human urine samples …

Analytical quality by design approach for the determination of imidazole in sildenafil API and its formulations using zwitterionic HILIC stationary phase

S Ntontis, E Tsanaktsidou, PD Tzanavaras… - … of Pharmaceutical and …, 2023 - Elsevier
Herein, the development of a HILIC method for the determination of imidazole (Imp E) in
sildenafil citrate API and its final formulations is reported. The main goal of this study was to …

A brief review on application of design of experiment for the analysis of pharmaceuticals using HPLC

SD Patil, SS Chalikwar - Annales Pharmaceutiques Françaises, 2023 - Elsevier
Summary The quality pioneer Dr. Joseph M. Juran first proposed the idea of quality by
design. According to him, pharmaceutical quality by design is an organised approach to …