Development and optimization of liquid chromatography analytical methods by using AQbD principles: Overview and recent advances
T Tome, N Žigart, Z Časar… - Organic process research …, 2019 - ACS Publications
This review presents the Analytical Quality by Design (AQbD) concept, an extension of
Quality by Design (QbD), which was introduced in 2004 by the US Food and Drug …
Quality by Design (QbD), which was introduced in 2004 by the US Food and Drug …
Mass spectrometry-based structure elucidation of small molecule impurities and degradation products in pharmaceutical development
Mass spectrometry (MS) has played a critical role in the identification of unknown small
molecules for many years. As such, it is also a pivotal technique in the structure elucidation …
molecules for many years. As such, it is also a pivotal technique in the structure elucidation …
An Overview of Degradation Strategies for Amitriptyline
C Comanescu, RC Racovita - International Journal of Molecular Sciences, 2024 - mdpi.com
Antidepressant drugs play a crucial role in the treatment of mental health disorders, but their
efficacy and safety can be compromised by drug degradation. Recent reports point to …
efficacy and safety can be compromised by drug degradation. Recent reports point to …
Comparison of AQbD and grid point search methodology in the development of micellar HPLC method for the analysis of cilazapril and hydrochlorothiazide dosage …
B Otašević, J Šljivić, A Protić, N Maljurić… - Microchemical …, 2019 - Elsevier
The development of stability-indicating method with isocratic elution mode based on micellar
liquid chromatography for the analysis of cilazapril, hydrochlorothiazide and their …
liquid chromatography for the analysis of cilazapril, hydrochlorothiazide and their …
Strategic approaches to elevate quality and sustainability in drug development: comprehensive pretomanid (PA-824) chemical stability study using QbD and green …
Regulatory agencies prioritize the safety and effectiveness of pharmaceuticals. The focus
here is to highlight the crucial need for control and oversight of Pretomanid (PMD), a …
here is to highlight the crucial need for control and oversight of Pretomanid (PMD), a …
QBD-driven HPLC method of eltrombopag olamine: Degradation pathway proposal, structure elucidation, and in silico toxicity prediction
B Jayagopal, S Murugesh - Journal of Pharmaceutical and Biomedical …, 2021 - Elsevier
Eltrombopag olamine is prescribed for chronic immune (idiopathic) thrombocytopenic
purpura (ITP). This work aims to investigate the formation of potential degradants of the drug …
purpura (ITP). This work aims to investigate the formation of potential degradants of the drug …
Comprehensive stability-indicating method development of Avanafil Phosphodiesterase type 5 inhibitor using advanced Quality-by-Design approach
Avanafil (AV) is the phosphodiesterase (PDE) type 5 inhibitor drug used in erectile
dysfunction, having pyrrolidine, pyrimidine, carboxamide, and chlorine as functional groups …
dysfunction, having pyrrolidine, pyrimidine, carboxamide, and chlorine as functional groups …
Determination of Three Alkyl Camphorsulfonates as Potential Genotoxic Impurities Using GC-FID and GC-MS by Analytical QbD
K Lee, W Yoo, JH Jeong - Separations, 2022 - mdpi.com
Camphorsulfonic acid salts are commonly used in the manufacturing production of active
pharmaceutical ingredients (APIs) and have the potential to form alkyl camphorsulfonates …
pharmaceutical ingredients (APIs) and have the potential to form alkyl camphorsulfonates …
Comparative study of the uv chemometrics, ratio spectra derivative and HPLC-QBD methods for the estimation of their simultaneous estimation in combined marketed …
The CARISOMA™ consists of carisoprodol (CAR), paracetamol (PCM) and caffeine (CAF)
used for fibromyalgia and osteoarthritis. The study discussed the comparative study of UV …
used for fibromyalgia and osteoarthritis. The study discussed the comparative study of UV …
Multivariate UV-chemometric and HPLC-QbD method for simultaneous estimation of vardenafil and dapoxetine in active pharmaceutical ingredients and its marketed …
MN Patel, CS Kothari - Current Analytical Chemistry, 2020 - ingentaconnect.com
Background: This manuscript focuses on Novel multivariate UV-chemometric method and
HPLC-QbD method for simultaneous determination of Vardenafil (VR) and Dapoxetine (DP) …
HPLC-QbD method for simultaneous determination of Vardenafil (VR) and Dapoxetine (DP) …