Results 131 to 140 of about 325 (160)

Chemometric-Based AQbD and Green Chemistry Approaches to Chromatographic Analysis of Remogliflozin Etabonate and Vildagliptin

Journal of AOAC INTERNATIONAL, 2022
Abstract Background According to the green chemistry approach, during method development, the usage of toxic and carcinogenic organic solvents should be avoided or minimized for the safety of the environment and analysts.
Pintu Prajapati, Hetal Ahir, Bhumika Prajapati, Shailesh Shah   +3 more
openaire   +2 more sources

Navigating the AQbD Landscape: Enhancing Quality Management in Liquid Chromatography Method Development

Biomedical Chromatography
ABSTRACTThe implementation of ‘Analytical Quality by Design’ (AQbD) is currently recognised as a methodical and scientific approach to liquid chromatographic (LC) method development. It begins with defining the Analytical Target Profile (ATP), identifying Critical Method Parameters (CMPs) and Critical Quality Attributes (CQAs) or responses.
J Joysa Ruby, Valliappan Kannappan, Selvakumar Kanthiah   +2 more
exaly   +3 more sources

Analytical quality by design (AQbD) in the ICHQ14 guidelines for analytical procedure development

Accreditation and Quality Assurance
V Ravichandiran, Ramalingam Peraman, Peraman Ramalingam   +2 more
exaly   +2 more sources

Mucoadhesion and rheology characterization in topical semisolid formulations: An AQbD-driven case study

International Journal of Pharmaceutics
This study outlines a framework for developing a texture analyzer-based mucoadhesion method integrated with rheology analysis for evaluating ointment formulations. Using an Analytical Quality by Design (AQbD) approach, key sources of variability affecting critical method variables (CMVs) were identified.
Lucas Chierentin, Vera Moura, Carla Vitorino   +2 more
exaly   +3 more sources

Development and validation of a novel isocratic RP-HPLC method using AQbD approach for the quantification of favipiravir [PDF]

European Journal of Pharmaceutical Sciences
In this study, the analytical quality by design (AQbD) approach was used to develop an eco-friendly reversed-phase high-performance liquid chromatography (RP-HPLC) method to identify and quantify favipiravir (FAV).A risk assessment identified factors significantly impacting method performance. Three high level risk factors (X1: ratio of solvent, X2: pH
Bence Sipos, Gabor Katona, Balázs Volk   +2 more
exaly   +3 more sources

A Robust HPLC Method for the Simultaneous Determination of Finerenone and Its Enantiomer Using AQbD

Chirality
ABSTRACTThe enantiomeric purity of Finerenone (FIN), a novel therapeutic for chronic kidney disease (CKD), is a critical quality attribute for ensuring patient safety. This study reports the first chiral HPLC method for the simultaneous determination of FIN and its enantiomer, developed and validated using a rigorous analytical quality by design (AQbD)
Badriah Saad Al‐Farhan, Ghada M. G. Eldin   +1 more
openaire   +2 more sources

An Estimation of Baricitinib by AQbD-driven UV Spectrophotometry Development and Validation Process

Letters in Drug Design & Discovery
Background: Baricitinib (BCTB) is a novel Janus Kinase (JAK) 1 and 2 inhibitor used in the therapy of rheumatoid arthritis, approved by the “Food and Drug Administration” in 2018. It has significant dose-dependent effectiveness and severe side effects. Thus, it is crucial to figure out its concentration in developed dosage forms. The literature search
Laxmi Rani, Ashwini Kumar Mishra, Neha S.L., Hitesh Kumar Dewangan, Pravat Kumar Sahoo   +4 more
openaire   +1 more source

Development of an AQbD driven HPLC method for the simultaneous estimation of caffeine and misoprostol in nanoparticle formulations

Analytical Methods
This graphical abstract depicts the HPLC-based simultaneous estimation of caffeine and misoprostol using, AQbD, followed by quantitative analysis of both drugs in chitosan based nanoparticles.
Nitasha Chauhan, Shiv Kumar, Shailendra Singh Rana, Shruti Chopra, Amit Bhatia   +4 more
openaire   +2 more sources

Analytical Quality by Design (AQbD) as a multiaddressable platform for co-encapsulating drug assays

Analytical Methods, 2018
AQbD provided a comprehensive framework for developing a reliable, effective, flexible band robust method for the routine analysis of the compounds in quality control laboratories.
João Basso, Maria Mendes, Tânia F. G. G. Cova, João J. Sousa, Alberto A. C. C. Pais, Carla Vitorino   +5 more
openaire   +1 more source

Analytical Quality by Design (AQbD): A Comprehensive Review with Emphasis on Risk Assessment Approaches

International Journal of Research in Pharmacy and Allied Science
Analytical Quality by Design (AQbD) is an innovative framework that enhances the robustness, reliability, and regulatory compliance of analytical methods through a systematic, science- and risk-based approach. This review article provides a comprehensive overview of the AQbD paradigm, with a particular emphasis on the integration and application of ...
Palak Jethava, Dr. Nilesh Patel
openaire   +1 more source