Results 71 to 80 of about 279 (161)

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.
Rajvi Agrawal, Rajendra Kotadiya
doaj   +1 more source

Application of Analytical Quality by Design (AQbD) in Developing Robust Methods for Herbicide Analysis-A Case Study on Metribuzin

International Journal of Pharmaceutical Research and Applications
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, Shifa Mammed Kutty K M, Saranya Mohan, Najah P A Meena P V   +3 more
openaire   +1 more source

International Approaches to the Development, Validation, and Change Management of Analytical Procedures (Review)

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. In 2023, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a new Guideline on Analytical Procedure Development (ICH Q14) and a revised version of the Guideline on ...
A. V. Fetisova, Zh. I. Aladysheva, N. V. Pyatigorskaya, O. A. Zyryanov, M. M. Marshalova   +4 more
doaj   +1 more source

A comprehensive RP-HPLC technique for analyzing disodium edetate and its degradation products in eye drops using AQbD and Six Sigma perspective

Reviews in Analytical Chemistry
The study presents the development of a novel, sustainable, and analytical quality by design (AQbD) driven RP-HPLC method to simultaneously identify disodium edetate in eye drops and its degradation products.
Alanazi Tahani Y. A., Alluhayb Abdullah H., Alsehli Bandar R., Binsaleh Ammena Y., Saleh Sayed M., Mohamed Mahmoud A.   +5 more
doaj   +1 more source

ICH Q14-Based Development of a Chaotropic Chromatography Method for the Determination of Olanzapine and Its Two Oxidative Degradation Products in Tablets

Analytica
Impurity profiling is of significant analytical and regulatory importance, particularly in the context of lifecycle quality management. A robust chaotropic chromatography method was developed for the determination of olanzapine and its two oxidative ...
Milena Rmandić, Marija Rašević, Kostas Gkountanas, Ana Protić, Anđelija Malenović, Yannis Dotsikas   +5 more
doaj   +1 more source

Sustainable RP-UPLC analysis of Nirogacestat for desmoid tumors using quality-by-design and green analytical chemistry

Green Chemistry Letters and Reviews
Quality-by-Design (QbD) and Green Analytical Chemistry (GAC) are used to develop a sustainable RP-UPLC method for detecting Nirogacestat hydrobromide (NGS) in bulk and pharmaceutical formulations.
Vanga Mohan Goud, Sarad Pawar Naik Bukke, Praveen Kumar Kusuma, Bayapa Reddy Narapureddy, Chandrashekar Thalluri   +4 more
doaj   +1 more source

RP-HPLC method development and validation of Abacavir, Lamivudine and Zidovudine in combined pharmaceutical dosage by analytical QbD

Discover Chemistry
An accurate, precise, robust, and green RP-HPLC method was developed for assessment of three antiviral medications, namely Abacavir (ABA), Lamivudine (LAMI), and Zidovudine (ZIDO) in combined pharmaceutical dosage form by Analytical Quality by Design ...
Divyesh Vanparia, Ronak R. Dedania, Zarna R. Dedania   +2 more
doaj   +1 more source

Development of a QAMS Analysis Method for Industrial Lanolin Alcohol Based on the Concept of Analytical Quality by Design

Separations
The Analytical Quality by Design (AQbD) concept was adopted to establish a quantitative analysis of multi-components with a single marker (QAMS) method for industrial lanolin alcohol, targeting cholesterol, lanosterol, and 24,25-dihydrolanosterol.
Kaidierya Abudureheman, Qinglin Wang, Hao Zhang, Xingchu Gong   +3 more
doaj   +1 more source

Analytical Quality by Design (AQBD) Assisted Development and Validation of HPTLC Method for Estimation of Rottlerin in Topical Patch Formulation

Pharmacognosy Research, 2023
Kaumudee Bodas, Vaibhav M Shinde, Deshmukh Vishal, Deshmukh Sheetal   +3 more
openaire   +1 more source

Stability-Indicating UPLC-PDA-QDa Methodology for Carvedilol and Felodipine in Fixed-Dose Combinations Using AQbD Principles

Scientia Pharmaceutica
The development of analytical procedures, in line with the recent regulatory requirements ICH Q2 (R2) and ICH Q14, is progressing, and it must be able to manage the entire life cycle of the methodology.
Jesús Alberto Afonso Urich, Viktoria Marko, Katharina Boehm, Raymar Andreina Lara Garcia, Anna Fedorko, Sharareh Salar-Behzadi, Dalibor Jeremic   +6 more
doaj   +1 more source