Results 71 to 80 of about 459 (187)

Analytical Quality by Design approach in the development of a green reversed-phase ultra-high performance liquid chromatography/high-resolution time-of-flight mass spectrometry method for the simultaneous analysis of synthetic antimicrobial and hypotensive peptides

Journal of Chromatography Open
The growing therapeutic interest in peptides from Tityus stigmurus scorpion venom and their analogues highlights the need for the development of robust analytical methods for these compounds.
Ana Roberta Pereira Johnson dos Anjos, Márcia Natália da Silveira Pinto, Dayanne Lopes Porto, Fabio Santos de Souza, Rui Oliveira Macedo, Matheus de Freitas Fernandes Pedrosa, Cícero Flávio Soares Aragão   +6 more
doaj   +1 more source

Analytical Quality by Design‐Based Stability‐Indicating UHPLC Method for Determination of Inavolisib in Bulk and Formulation

SEPARATION SCIENCE PLUS, Volume 8, Issue 8, August 2025.
ABSTRACT Inavolisib is a novel, potent, and selective phosphatidylinositol‐3‐kinase alpha inhibitor recently approved for the treatment of phosphatidylinositol‐3‐kinase alpha‐mutated breast cancer. This research focuses on the UHPLC method development and method validation of a stability‐indicating RP‐UHPLC method for the quantification of inavolisib ...
Ashwinkumar matta, Raja Sundararajan
wiley   +1 more source

Chromatographic study of sitagliptin and ertugliflozin under quality-by-design paradigm

Brazilian Journal of Pharmaceutical Sciences, 2023
The present study entails the systematic development and validation of a stability-indicating RP-HPLC method for the analysis of sitagliptin and ertugliflozin in a fixed-dose combination.
Sunitha Gurrala, Shivaraj , Panikumar Durga Anumolu, Haripriya D, Subrahmanyam CVS   +4 more
doaj   +1 more source

Environmental benign analytical quality by design and UPLC method development for Betamethasone and Calcipotriene in ointment

Journal of Taibah University for Science, 2021
The present study aimed to estimate Betamethasone and Calcipotriene in bulk and ointment formulation using a validated UPLC method by applying analytical quality design with green analytical chemistry principles.
Kanaka Parvathi Kannaiah, Abimanyu Sugumaran   +1 more
doaj   +1 more source

VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GLECAPREVIR AND PIBRENTASVIR BY USING ANALYTICAL QUALITY BY DESIGN (AQBD) METHOD

International Journal of Research in Ayurveda and Pharmacy, 2023
The quantitative measurement of Glecaprevir and Pibrentasvir has been created using a simple, quick, precise, sensitive, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) method. It is more difficult to analyse varying amounts of pharmaceutical active medicinal ingredients in dosage forms without interferences.
Nithiyananthan K, Prasada Rao KVS
openaire   +1 more source

Quality by Design Based Chromatography Technique Development and Validation for the Medicine Venetoclax (for Chronic Leukemia), in the Context of Impurities Including Degradation Products

Biomedical Chromatography, Volume 39, Issue 5, May 2025.
ABSTRACT The present research study describes the Venetoclax (VEN)‐related substances test method using RP‐HPLC/DAD techniques. It was developed and validated according to ICH Q14 and Q2(R2) guidelines. The substances were separated using an X‐Bridge Phenyl column (150 mm × 4.6 mm, 3.5 μm) and a gradient program.
Rajeshwari Dandabattina, Karuna Sree Merugu, Lova Gani Raju Bandaru, Haridasyam Sharathbabu, Rambabu Gundla, Naresh Kumar Katari   +5 more
wiley   +1 more source

Determination of Bupropion and Its Impurities via a Chaotropic Chromatography Method Following Analytical Quality-by-Design Principles for Method Development

Pharmaceuticals, 2022
A novel chaotropic chromatography method for the quantitative determination of bupropion and its impurities, following analytical quality-by-design (AQbD) principles, is presented.
Kostas Gkountanas, Anđelija Malenović, Yannis Dotsikas   +2 more
doaj   +1 more source

Green Analytical Stability Indicating UHPLC Method for the Quantification of Related Impurities in Vonoprazan Formulation Applying Analytical Quality by Design

SEPARATION SCIENCE PLUS, Volume 8, Issue 4, April 2025.
ABSTRACT Vonoprazan is an innovative potassium competitive acid blocker and has emerged as an effective alternative to proton pump inhibitors for the treatment of acid‐related disorders. High‐performance liquid chromatography was performed using a Symmetry C18 column (150 mm × 4.6 mm ID, 3.0 µm) with a mobile phase flow rate of 1.0 mL/min. Mobile phase
Ashwinkumar Matta, Raja Sundararajan
wiley   +1 more source

Potency Assay Variability Estimation in Practice

Pharmaceutical Statistics, Volume 24, Issue 1, January/February 2025.
Abstract During the drug development process, testing potency plays an important role in the quality assessment required for the manufacturing and marketing of biologics. Due to multiple operational and biological factors, higher variability is usually observed in bioassays compared with physicochemical methods.
Hang Li, Tomasz M. Witkos, Scott Umlauf, Christopher Thompson   +3 more
wiley   +1 more source

Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process

Pharmaceutics, 2020
A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have been established
Juan Almeida, Mariana Bezerra, Daniel Markl, Andreas Berghaus, Phil Borman, Walkiria Schlindwein   +5 more
doaj   +1 more source