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 +3 more sources
Analytical Quality by Design (AQbD) applies Quality by Design principles to analytical method development, aiming to design methods that are robust, well-understood, and life cycle managed. Herbicide residue analysis (monitoring active compounds and metabolites in formulations, food, soil, and water) presents challenges of trace-level detection, matrix
Wafa T Wafa T +3 more
openaire +2 more sources
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 +2 more
doaj +2 more sources
Characterisation of Antisense Oligonucleotides by Ion-Pair Reversed-Phase UHPLC-HRMS: Method development using Design of Experiments. [PDF]
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 +4 more
europepmc +2 more sources
Analytical Quality by Design-Compliant Development of a Cyclodextrin-Modified Micellar ElectroKinetic Chromatography Method for the Determination of Trimecaine and Its Impurities [PDF]
In 2022, the International Council for Harmonisation released draft guidelines Q2(R2) and Q14, intending to specify the development and validation activities that should be carried out during the lifespan of an analytical technique addressed to assess ...
Dousa M. +9 more
core +4 more sources
Exploring Analytical Quality by Design (AQbD) Enabled RP-HPLC Method for Carvedilol
Krantisinha Hanumant Randive +2 more
openaire +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]
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 S +5 more
europepmc +2 more sources
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 +3 more
doaj +1 more source
Application of quality-by-design approach in the analytical method development for quantification of sugars in sugarcane honey by reversed-phase liquid chromatography [PDF]
Produced in Madeira Island from regional sugarcane cultivars through a traditional manufacturing and storage process, sugarcane honey (SCH) is a black syrup recognized by its excellent quality.
Câmara, José S. +4 more
core +1 more source
Green analytical procedures replace harmful organic modifiers with green solvents without affecting chromatographic performance, enabling industries and research laboratories to develop green analytical methods.
Naveenarani Dharuman +2 more
doaj +1 more source

