Drilling into “Quality by Design” approach for analytical methods

L Chiarentin, C Gonçalves, C Augusto… - Critical Reviews in …, 2024 - Taylor & Francis
The need for consistency in analytical method development reinforces the dependence of
pharmaceutical product development and manufacturing on robust analytical data. The …

Robustness evaluation in analytical methods optimized using experimental designs

SLC Ferreira, AO Caires, TS Borges, AMDS Lima… - Microchemical …, 2017 - Elsevier
Robustness has been defined as being the capacity of an analytical procedure to produce
unbiased results when small changes in the experimental conditions are made voluntarily …

UHPLC method for multiproduct pharmaceutical analysis by Quality-by-Design

L Ferey, A Raimbault, I Rivals, K Gaudin - Journal of Pharmaceutical and …, 2018 - Elsevier
Abstract An innovative Analytical Quality-by-Design (AQbD) methodology was followed to
develop a specific and robust UHPLC method for the simultaneous separation of 16 active …

Quality by design strategy for simultaneous HPLC determination of bromhexine HCl and its metabolite ambroxol HCl in dosage forms and plasma

HM El-Sayed, H Hashem - Chromatographia, 2020 - Springer
The quality by design strategy was applied for the simultaneous chromatographic
quantification of a binary mixture of bromhexine HCl and its pharmacologically active …

Tolerance intervals modeling for design space of a salt assisted liquid-liquid microextraction of trimethoprim and six common sulfonamide antibiotics in environmental …

HI Mokhtar, RA Abdel-Salam, GM Hadad - Journal of Chromatography a, 2019 - Elsevier
Sulfonamides and trimethoprim combinations have been used extensively as antimicrobial
agents for prevention and treatment of human and animal infections. Although many …

[PDF][PDF] Key information related to quality by design (QbD) applications in analytical methods development

AS Araújo, DF Andrade, DV Babos, J Pricylla… - Braz. J. Anal …, 2021 - brjac.com.br
In this review, quality by design (QbD) initiatives are described as applications for many
types of processes, such as in the pharmaceutical industry, biotechnology field, and for …

Analytical quality by design oriented development of the UPLC method for analysing multiple pharmaceutical process intermediates: A case study of Compound …

Y Tai, D Ren, W Zhao, H Qu, H Xiong, X Gong - Microchemical Journal, 2023 - Elsevier
This work presented the integration of the Analytical Quality by Design concept in
developing a UPLC method for the quantification of saponins and phenolic acids in two …

Optimization and validation in liquid chromatography using design of experiments

L Latrous - Chemistry Africa, 2022 - Springer
Faced to the large number of potential factors in liquid chromatography, the analyst is often
led to determine through his experience the parameters to be studied. Experimental designs …

Multivariate analysis of perampanel in pharmaceutical formulations using RP-HPLC

MM Elhawi, WS Hassan, R El-Sheikh, HM El-Sayed - Chromatographia, 2020 - Springer
A new, sensitive, robust RP-HPLC method was developed using quality by design (QbD)
approach for the determination of perampanel in pharmaceutical tablets. Screening of five …

Simultaneous determination of anti-diabetic drugs in their combined dosage forms using HPLC: an experimental design approach

MA Mukthinuthalapati, V Bukkapatnam… - Journal of …, 2019 - academic.oup.com
A liquid chromatographic method has been established for the separation of five presently
existing anti-diabetic drugs—metformin, pioglitazone, glibenclamide, glimepiride and …