Results 21 to 30 of about 833 (196)

Green RP-HPLC method for estimation of trigonelline: AQbD based development, validation, and application to nanoformulations. [PDF]

BMC Chem
Trigonelline is an alkaloidal plant derived bioactive compound reported for its various pharmacological activities. Recent advances in the utilization of this compound in drug development have highlighted the importance of establishing a reproducible and efficient analytical method for estimating trigonelline (TRG) in both its pure form and formulated ...
Kothapalli P, Vasanthan M.
europepmc   +3 more sources

Green RP-UPLC Method for Simultaneous Determination of Cyclopentolate and Organic Impurities Using DoE and Sustainability Metrics. [PDF]

Int J Anal Chem
A significant improvement in sustainability and efficiency is achievable through green and white chemistry. As part of this study, sustainability assessment tools were used to assess the environmental impact and practicality of an innovative, straightforward RP‐UPLC method to analyze cyclopentolate (CLO) and its organic impurities simultaneously in ...
Alsehli BR, Alluhayb AH, Al-Khateeb LA, Saleh SM, Binsaleh AY, Mohamed MA.   +5 more
europepmc   +2 more sources

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

BMC Chem
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.
Gohel J, Patel A, Kotadiya R.
europepmc   +2 more sources

AQbD-guided stability indicating HPLC method for azelnidipine and chlorthalidone fixed-dose combination tablet: a green approach

Journal of Taibah University for Science
This study developed a stability-indicating RP-HPLC method for quantifying azelnidipine and chlorthalidone in fixed-dose formulations using Analytical Quality by Design (AQbD) principles.
Rajendra Kotadiya
exaly   +3 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

Definições e escopo dos elementos-chave do Analytical Quality by Design (AQbD) para o desenvolvimento de métodos na indústria farmacêutica

Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia, 2023
Introdução: O setor farmacêutico está em constante evolução e é altamente regulado com normas para garantir eficácia, segurança e qualidade dos medicamentos.
Rosemberg Bernardez Moure, Flávia Furtado de Mendonça de Sousa, Diogo Dibo do Nascimento, Jorge Lima de Magalhães, Camila Areias de Oliveira, Livia Deris Prado   +5 more
doaj   +1 more source

Perspectives in modeling and model validation during analytical quality by design chromatographic method evaluation: a case study

AAPS Open, 2021
Design of experiments (DOE)-based analytical quality by design (AQbD) method evaluation, development, and validation is gaining momentum and has the potential to create robust chromatographic methods through deeper understanding and control of ...
Yongzhi Dong, Zhimin Liu, Charles Li, Emily Pinter, Alan Potts, Tanya Tadey, William Weiser   +6 more
doaj   +1 more source

Development of a Unified Reversed-Phase HPLC Method for Efficient Determination of EP and USP Process-Related Impurities in Celecoxib Using Analytical Quality by Design Principles

Molecules, 2020
This article presents the development of a reversed-phase (RP) high-performance liquid chromatographic (HPLC) method for determination of process-related impurities in a celecoxib drug substance following Analytical Quality by Design (AQbD) principles ...
Tim Tome, Zdenko Časar, Aleš Obreza
doaj   +1 more source

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
openaire   +3 more sources