Results 11 to 20 of about 299 (155)

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

Development of a green chemistry based bioanalytical method using response surface methodology to analyze febuxostat and indomethacin in rabbit plasma [PDF]

Scientific Reports
This 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, Piyongsola, Biprojit Paul, Koushik Nandan Dutta, Bhargab Jyoti Sahariah, Manoj Kumar Deka, Amit kumar Das, Manish Majumder   +7 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

Analytical quality by design (AQbD) based optimization of RP-UPLC method for determination of nivolumab and relatlimab in bulk and pharmaceutical dosage forms

Future Journal of Pharmaceutical Sciences
Background The Analytical Quality by Design (AQbD) methodology extends the application of Quality by Design (QbD) principles to the management of the analytical procedure life cycle, encompassing method creation, optimization, validation, and continuous ...
Mohana Vamsi Nuli, Ramanjaneyulu Seemaladinne, Anil Kumar Tallam   +2 more
doaj   +2 more sources

Analytical quality by design (AQbD) approach for the simultaneous quantification of FDC in a cardiovascular drug by RP-HPLC method

Future Journal of Pharmaceutical Sciences
Background A sustainable and stability-indicating reversed-phase high-pressure liquid chromatography (RP-HPLC) method has been developed for the simultaneous estimation of chlorthalidone (CHL), Amlodipine (AML), and olmesartan medoxomil (OLM) in a ...
Varsha Thorat, Sudhakar Alave, Vijay Bagul   +2 more
doaj   +2 more sources

Quality by Design-Based Development of a Robust LC Method for Simultaneous Estimation of Process- and Degradation-Related Impurities in Rifapentine Drug Product for the Treatment of Active and Latent Tuberculosis. [PDF]

Biomed Chromatogr
ABSTRACT A precise, robust, and stability‐indicating liquid chromatographic (LC) method coupled with a photodiode array (PDA) detector was developed and validated for the quantitative estimation of rifapentine, an essential therapeutic agent for both active and latent tuberculosis (TB).
Korikana SP, Battula SR, Konduru N, Kurnool A, Vemuri DK, Dantinapalli VLS.   +5 more
europepmc   +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

Characterisation of Antisense Oligonucleotides by Ion-Pair Reversed-Phase UHPLC-HRMS: Method development using Design of Experiments. [PDF]

J Mass Spectrom
ABSTRACT The quality control of therapeutic antisense oligonucleotides (ASOs) poses significant analytical challenges due to the complexity of their synthesis and degradation processes and the need to ensure the safety and efficacy of active pharmaceutical ingredients (APIs).
Triolo A, Tavani F, Barnini P, Furlanetto S, Orlandini S.   +4 more
europepmc   +2 more sources

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

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   +1 more source