Results 11 to 20 of about 325 (160)

Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants [PDF]

Plants, 2022
Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery.
Geonha Park, Young Pyo Jang
exaly   +6 more sources

Integrating analytical quality by design into bioanalytical method development: an HPLC-FLD method for quantification of alectinib in biological matrix [PDF]

BMC Chemistry
This 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, Nahyun Koo, Min Ju Kim, Kyeong-Ryoon Lee, Yoon-Jee Chae   +4 more
doaj   +2 more sources

Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles

Molecules, 2021
A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC®) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form.
Jesus Alberto Afonso Urich, Amrit Paudel   +1 more
exaly   +3 more sources

Rheology of Complex Topical Formulations: An Analytical Quality by Design Approach to Method Optimization and Validation [PDF]

Pharmaceutics, 2023
Analytical method validation ensures that a method provides trustworthy information about a particular sample when applied in accordance with the predefined protocol. According to regulatory standards, the rheological characteristics of topically applied
Lucas Chiarentin, Catarina Cardoso, Margarida Miranda, Carla Vitorino   +3 more
doaj   +2 more sources

AQbD-novel strategy for analytical methods

Future Journal of Pharmaceutical Sciences
Background Analytical Quality by Design (AQbD) has emerged as a pivotal paradigm in the realm of analytical chemistry, revolutionizing the approach to method development and validation. This innovative strategy integrates principles of Quality by Design (
Amruta Bairagi, Rutuja Kothrukar, Hemant Chikhale, Sreya Kosanam, Laxmikant Borse   +4 more
doaj   +2 more sources

Increasing Analytical Quality by Designing a Thin-Layer Chromatography Scanner Method for the Determination of the Radiochemical Purity of Radiopharmaceutical Sodium Iodide ¹³¹I Oral Solution [PDF]

Molecules
The goal of this study was to apply the principles of analytical quality by design (AQbD) to the analytical method for determining the radiochemical purity (PQR) of the radiopharmaceutical sodium iodide 131I oral solution, utilizing thin-layer ...
Miguel Vasquez-Huaman, Américo Castro-Luna, Norma Julia Ramos-Cevallos, Donald Ramos-Perfecto, Mario Alcarraz-Curi, Jacqueline Segura-Vasquez, Danny Cáceres-Antaurco   +6 more
doaj   +2 more sources

AQbD-driven development of a green RP-HPLC method for nirogacestat with LC–MS structural elucidation [PDF]

BMC Chemistry
Nirogacestat (NGT), a recently approved γ-secretase inhibitor for desmoid tumors, requires sensitive and sustainable analytical methods for impurity profiling.
Jayanthi Sabi, Kanaka Parvathi Kannaiah, Hemanth Kumar Chanduluru, Srinivas Nakka, Samar H. Elagamy, Reem H. Obaydo   +5 more
doaj   +2 more sources

Integrating green analytical chemistry and analytical quality by design: an innovative approach for RP-UPLC method development of ensifentrine in bulk and inhalation formulations [PDF]

BMC Chemistry
Background Chronic obstructive pulmonary disease (COPD) is a significant global health issue, worsened by pollution and modernisation. Ensifentrine (EFT), a new dual inhibitor of phosphodiesterase PDE3 and PDE4, is being developed for inhalation to ...
Mohan Goud Vanga, Sarad Pawar Naik Bukke, Praveen Kumar Kusuma, Bayapa Reddy Narapureddy, Chandrashekar Thalluri   +4 more
doaj   +2 more sources

AQbD-Based UPLC-ELSD Method for Quantifying Medium Chain Triglycerides in Labrafac™ WL 1349 for Nanoemulsion Applications [PDF]

Molecules
In 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, Viktoria Marko, Dalibor Jeremic, Carolin Tetyczka, Philippe Caisse, Jesús Alberto Afonso Urich   +5 more
doaj   +2 more sources

New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods [PDF]

Molecules, 2022
Capillary electrophoresis (CE) is a potent method for analyzing chiral substances and is commonly used in the enantioseparation and chiral purity control of pharmaceuticals from different matrices.
Serena Orlandini, Gabriel Hancu, Zoltán-István Szabó, Adriana Modroiu, Lajos-Attila Papp, Roberto Gotti, Sandra Furlanetto   +6 more
doaj   +2 more sources