AQbD-driven development of a green RP-HPLC method for nirogacestat with LC–MS structural elucidation [PDF]
BMC ChemistryNirogacestat (NGT), a recently approved γ-secretase inhibitor for desmoid tumors, requires sensitive and sustainable analytical methods for impurity profiling.
Jayanthi Sabi +5 more
doaj +2 more sources
Chromatographic study of sitagliptin and ertugliflozin under quality-by-design paradigm [PDF]
Brazilian Journal of Pharmaceutical Sciences, 2023 The present study entails the systematic development and validation of a stability-indicating RP-HPLC method for the analysis of sitagliptin and ertugliflozin in a fixed-dose combination.
Sunitha Gurrala +4 more
doaj +3 more sources
Determination of Bupropion and Its Impurities via a Chaotropic Chromatography Method Following Analytical Quality-by-Design Principles for Method Development [PDF]
Pharmaceuticals, 2022 A novel chaotropic chromatography method for the quantitative determination of bupropion and its impurities, following analytical quality-by-design (AQbD) principles, is presented.
Kostas Gkountanas +2 more
doaj +3 more sources
Journal of Medical pharmaceutical and allied sciences, 2021 The current analytical exploration illustrated developing a reversed-phase high-performance liquid chromatography (RP-HPLC) technique and consequent substantiation for analyzing lamotrigine (LAM) active pharmaceutical ingredient (API) using a Quality-by-design (QbD) approach (Central Composite Design), in bulk product as well as in the tablet ...
M. Puranik
openaire +2 more sources
Quality by design‐guided development of a capillary electrophoresis method for the simultaneous chiral purity determination and impurity profiling of tamsulosin [PDF]
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.
Hancu, Gabriel +3 more
core +2 more sources
Integrating analytical quality by design into bioanalytical method development: an HPLC-FLD method for quantification of alectinib in biological matrix [PDF]
BMC ChemistryThis study presents the development and validation of a fluorescence-based high-performance liquid chromatography (HPLC) method for the quantification of alectinib in rat plasma, with a focus on the application of Analytical Quality by Design (AQbD) to ...
Eun Ji Lee +4 more
doaj +2 more sources
Development of a green chemistry based bioanalytical method using response surface methodology to analyze febuxostat and indomethacin in rabbit plasma [PDF]
Scientific ReportsThis research established an environmentally friendly and sustainable approach to measure Febuxostat and Indomethacin levels in rabbit plasma samples, utilizing isocratic liquid chromatography guided by green analytical chemistry principles and ...
Akramul Ansary +7 more
doaj +2 more sources
International Journal of Research in Ayurveda and Pharmacy, 2023 The quantitative measurement of Glecaprevir and Pibrentasvir has been created using a simple, quick, precise, sensitive, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) method. It is more difficult to analyse varying amounts of pharmaceutical active medicinal ingredients in dosage forms without interferences.
Nithiyananthan K, Prasada Rao KVS
openaire +2 more sources
AQbD-Based UPLC-ELSD Method for Quantifying Medium Chain Triglycerides in Labrafac™ WL 1349 for Nanoemulsion Applications [PDF]
MoleculesIn response to recent regulatory guidelines, including ICH (International Council for Harmonisation) Q2 (R2) and Q14, we developed a UPLC-ELSD method to quantify Medium-Chain Triglycerides (MCTs) in Labrafac™ WL 1349 for nanoemulsion applications.
Alessio Gaggero +5 more
doaj +2 more sources