Results 21 to 30 of about 299 (155)

Analytical Quality by Design-Guided Optimisation and Validation of a Short-Run Stability-Indicating Reverse-Phase Ultra-Fast Liquid Chromatography (RP-UFLC) Method for the Quantitation of Nonivamide. [PDF]

Biomed Chromatogr
ABSTRACT Nonivamide (NON), a capsaicin analogue with similar pharmacological effects, is used in pain management, yet limited information exists on its accurate quantification by reverse‐phase liquid chromatography. A cost‐effective, efficient and precise RP‐HPLC method was developed, optimised using response surface methodology (central composite ...
Mahlangu P, Poka MS, Makoni PA, Witika BA.   +3 more
europepmc   +2 more sources

Environmental benign RP-HPLC method for the simultaneous estimation of anti-hypertensive drugs using analytical quality by design

Green Chemistry Letters and Reviews, 2023
Green analytical procedures replace harmful organic modifiers with green solvents without affecting chromatographic performance, enabling industries and research laboratories to develop green analytical methods.
Naveenarani Dharuman, Karunanidhi Santhana Lakshmi, Manikandan Krishnan   +2 more
doaj   +1 more source

Quality by design‐guided development of a capillary electrophoresis method for the simultaneous chiral purity determination and impurity profiling of tamsulosin

Journal of Separation Science, Volume 46, Issue 24, December 2023., 2023
Analytical Quality by Design principles using the design of experiments were applied for the development of a capillary electrophoresis method for the determination of enantiomeric purity and chemically related impurities of tamsulosin. From initial scouting experiments, a dual cyclodextrin (CD) system composed of sulfated β‐CD and carboxymethyl‐α‐CD ...
Adriana Modroiu, Sulaiman Krait, Gabriel Hancu, Gerhard K. E. Scriba   +3 more
wiley   +1 more source

Perspectives in modeling and model validation during analytical quality by design chromatographic method evaluation: a case study

AAPS Open, 2021
Design of experiments (DOE)-based analytical quality by design (AQbD) method evaluation, development, and validation is gaining momentum and has the potential to create robust chromatographic methods through deeper understanding and control of ...
Yongzhi Dong, Zhimin Liu, Charles Li, Emily Pinter, Alan Potts, Tanya Tadey, William Weiser   +6 more
doaj   +1 more source

Definições e escopo dos elementos-chave do Analytical Quality by Design (AQbD) para o desenvolvimento de métodos na indústria farmacêutica

Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia, 2023
Introdução: O setor farmacêutico está em constante evolução e é altamente regulado com normas para garantir eficácia, segurança e qualidade dos medicamentos.
Rosemberg Bernardez Moure, Flávia Furtado de Mendonça de Sousa, Diogo Dibo do Nascimento, Jorge Lima de Magalhães, Camila Areias de Oliveira, Livia Deris Prado   +5 more
doaj   +1 more source

Strategies for capillary electrophoresis: Method development and validation for pharmaceutical and biological applications—Updated and completely revised edition

ELECTROPHORESIS, Volume 44, Issue 17-18, Page 1279-1341, September 2023., 2023
Abstract This review is in support of the development of selective, precise, fast, and validated capillary electrophoresis (CE) methods. It follows up a similar article from 1998, Wätzig H, Degenhardt M, Kunkel A. “Strategies for capillary electrophoresis: method development and validation for pharmaceutical and biological applications,” pointing out ...
Finja Krebs, Holger Zagst, Matthias Stein, Ratih Ratih, Robert Minkner, Mais Olabi, Sophie Hartung, Christin Scheller, Blanca H. Lapizco‐Encinas, Cari Sänger‐van de Griend, Carlos D. García, Hermann Wätzig   +11 more
wiley   +1 more source

Process analytical technique (PAT) miniaturization for monoclonal antibody aggregate detection in continuous downstream processing

Journal of Chemical Technology &Biotechnology, Volume 97, Issue 9, Page 2347-2364, September 2022., 2022
Abstract The transition to continuous biomanufacturing is considered the next step to reduce costs and improve process robustness in the biopharmaceutical industry, while also improving productivity and product quality. The platform production process for monoclonal antibodies (mAbs) is eligible for continuous processing to lower manufacturing costs ...
Mariana N São Pedro, Marieke E Klijn, Michel HM Eppink, Marcel Ottens   +3 more
wiley   +1 more source

Sixteen capillary electrophoresis applications for viral vaccine analysis

ELECTROPHORESIS, Volume 43, Issue 9-10, Page 1068-1090, May 2022., 2022
Abstract A broad range of CE applications from our organization is reviewed to give a flavor of the use of CE within the field of vaccine analyses. Applicability of CE for viral vaccine characterization, and release and stability testing of seasonal influenza virosomal vaccines, universal subunit influenza vaccines, Sabin inactivated polio vaccines ...
Lars Geurink, Ewoud van Tricht, Debbie van der Burg, Gerard Scheppink, Bojana Pajic, Justin Dudink, Cari Sänger–van de Griend   +6 more
wiley   +1 more source

Expediting Disulfiram Assays through a Systematic Analytical Quality by Design Approach

Chemosensors, 2021
An Analytical Quality by Design (AQbD) approach is presented, aiming at the development and validation of an HPLC method for the quantification of disulfiram and copper diethyldithiocarbamate in lipid nanoparticles.
João Basso, Maria Luísa Ramos, Alberto Pais, Rui Vitorino, Ana Fortuna, Carla Vitorino   +5 more
doaj   +1 more source

Integrated Analytical Quality by Design (AQbD) Approach for the Development and Validation of Bioanalytical Liquid Chromatography Method for Estimation of Valsartan [PDF]

Journal of Chromatographic Science, 2020
Abstract The present studies describe the systematic development and validation of a simple, rapid, sensitive and cost-effective reversed-phase high-performance liquid chromatographic bioanalytical method for the estimation of valsartan in rat plasma employing analytical quality by design (AQbD) principles quality risk management was ...
Shantanu, Bandopadhyay, Sarwar, Beg, O P, Katare, Teenu, Sharma, Bhupinder, Singh   +4 more
openaire   +2 more sources