Results 11 to 20 of about 796 (185)

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

AQbD Approach Applied to NIR in a Complex Topical Formulation: Bifonazole as Case Study. [PDF]

Pharmaceutics
Background: A key challenge in modern pharmaceutical research is developing predictive models for drug formulation behavior. Since permeability is closely linked to molecular properties, considering a broad of characteristics is essential for building reliable predictive tools.
Chiarentin L, Moura V, Pais AACC, Vitorino C.   +3 more
europepmc   +3 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

Analytical Quality by Design Approach of Reverse-Phase High-Performance Liquid Chromatography of Atorvastatin: Method Development, Optimization, Validation, and the Stability-Indicated Method

International Journal of Analytical Chemistry, 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.
Nabil K. Alruwaili
doaj   +2 more sources

Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles [PDF]

ACS Omega, 2020
Venetoclax is an emerging drug for the treatment of various types of blood cancers. It was first approved in 2016 for the treatment of relapsed and refractory chronic lymphocytic leukemia. Later, the indications expanded, and multiple research as well as clinical studies are still conducted involving venetoclax.
Nina Žigart, Zdenko Časar
doaj   +3 more sources

Optimization of green LC-MS method for rosuvastatin and teneligliptin using AQbD chemometric approach

Journal of Applied Pharmaceutical Research
Background: Rosuvastatin combined with Teneligliptin formulation is commonly used in the treatment of Diabetic dyslipidaemia. However, only a few analytical methods have been published for the examination of this drug in a synthetic mixture or in a ...
S R Aswathy, Hemnath Elango
doaj   +3 more sources

Green UHPLC approach for the quantitative determination of tiopronin residues in cleaning validation processes [PDF]

BMC Chemistry
This study presents the development and validation of a novel reverse-phase ultra-high-performance liquid chromatography (UHPLC) method for quantifying tiopronin residues on manufacturing equipment surfaces as part of cleaning validation.
Jagdish Gohel, Ajay Patel, Rajendra Kotadiya   +2 more
doaj   +2 more sources

A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development. [PDF]

Electrophoresis
ABSTRACT The ICH Q14 guideline introduces a structured framework for analytical method development based on Analytical Quality by Design (AQbD) principles, aiming to ensure robust, reliable, and fit‐for‐purpose methods throughout the product lifecycle.
Tricht EV, Sänger-van de Griend CE.
europepmc   +2 more sources

PDA-CAD method for the determination of magnesium, pyridoxine and thiamine in a dietary supplement supported by analytical quality by design methodology [PDF]

Arhiv za farmaciju, 2021
In this research, Analytical Quality by Design (AQbD) methodology was used to develop the HILIC-PDA-CAD method for the determination of magnesium, pyridoxine and thiamine content in a dietary supplement. Experiments were conducted on the Dionex Ulitimate
Rmandić Milena, Rađenović Miloš, Stanković Jovana, Protić Ana, Otašević Biljana, Malenović Anđelija   +5 more
doaj   +1 more source

Discriminative Dissolution Method Development Through an aQbD Approach

AAPS PharmSciTech, 2023
AbstractUsing a one-factor-at-a-time approach for dissolution method and discrimination analysis can be time-consuming and may not yield the optimal and discriminative method. To address this, we have developed a two-stage workflow for the dissolution method development followed by demonstration of discrimination power through an analytical Quality by ...
Hongbo Chen, Rui Wang, John-David McElderry   +2 more
openaire   +2 more sources