International Journal of Analytical Chemistry, Volume 2021, Issue 1, 2021., 2021 The use of analytical quality by design (AQbD) approach in the optimization of the high‐performance liquid chromatography (RP‐HPLC) method is a novel tool. Three factors and three levels of Box–Behnken statistical design (BBD) were used for method optimization and analysis of atorvastatin.
Nabil K. Alruwaili, Günther K. Bonn
wiley +1 more source
Potency Assay Variability Estimation in Practice. [PDF]
Pharm StatAbstract During the drug development process, testing potency plays an important role in the quality assessment required for the manufacturing and marketing of biologics. Due to multiple operational and biological factors, higher variability is usually observed in bioassays compared with physicochemical methods.
Li H, Witkos TM, Umlauf S, Thompson C.
europepmc +2 more sources
Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach [PDF]
, 2020 A UPLC-MS method for the estimation of atazanavir sulfate was developed using the “analytical quality by design” approach. The critical chromatographic quality attributes identified were retention time, theoretical plates and peak tailing.
CHANDAN RAVANDUR SHIVANNA +2 more
core +2 more sources
Quality by Design Based Chromatography Technique Development and Validation for the Medicine Venetoclax (for Chronic Leukemia), in the Context of Impurities Including Degradation Products. [PDF]
Biomed ChromatogrABSTRACT The present research study describes the Venetoclax (VEN)‐related substances test method using RP‐HPLC/DAD techniques. It was developed and validated according to ICH Q14 and Q2(R2) guidelines. The substances were separated using an X‐Bridge Phenyl column (150 mm × 4.6 mm, 3.5 μm) and a gradient program.
Dandabattina R +5 more
europepmc +2 more sources
Robust optimization of gradient RP HPLC method for simultaneous determination of ivabradine and its eleven related substances by AQbD approach [PDF]
, 2022 This paper is aimed at developing a gradient elution reversed-phase high-performance liquid chromatography (RP-HPLC) method for the separation of a complex mixture composed of ivabradine and its eleven impurities, in a reasonable timeframe.
Agbaba, Danica +5 more
core +1 more source
Vigilância Sanitária em Debate, 2023 Introdução: O setor farmacêutico está em constante evolução e é altamente regulado com normas para garantir eficácia, segurança e qualidade dos medicamentos. O Quality by Design (QbD) é uma abordagem sistemática para o desenvolvimento farmacêutico, fundamentada no conhecimento científico e no gerenciamento do risco associado ao processo de fabricação ...
Rosemberg Bernardez Moure +5 more
openaire +2 more sources
Application of Analytical Quality by Design (AQbD) approach in in vitro release test (IVRT) method development in the case of semisolid topical formulations [PDF]
Szoleczky Réka
core +2 more sources
Analytical Method Validation: A Comprehensive Review of Current Practices [PDF]
Analytical method validation is a critical process in industries such as pharmaceuticals, food safety, biotechnology, and environmental monitoring. It guarantees reliability, reproducibility, and compliance with regulatory obligations. This review covers
Sachin S. Shinde, Dr. Preeti Khulbe
core +5 more sources
Analytical quality by design using a D-optimal design and parallel factor analysis in an automatic solid phase extraction system coupled to liquid chromatography. Determination of nine PAHs in coffee samples [PDF]
, 2023 Optimizing a multi-residue analysis when using an automatic SPE (solid phase extraction) system and complex matrices becomes a difficult problem because of the large number of experimental factors that can influence the recovery of the analytes ...
Arce Antón, Mar +3 more
core +1 more source
Determination of Bupropion and Its Impurities via a Chaotropic Chromatography Method Following Analytical Quality-by-Design Principles for Method Development [PDF]
, 2022 A novel chaotropic chromatography method for the quantitative determination of bupropion and its impurities, following analytical quality-by-design (AQbD) principles, is presented.
Dotsikas, Yannis +2 more
core +1 more source