Results 61 to 70 of about 325 (160)

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

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

AQbD assisted UPLC method development and validation of tirzepatide in bulk and pharmaceutical dosage form

Journal of Applied Pharmaceutical Research
Background: Tirzepatide is a USFDA-approved (2023) synthetic drug that primarily targets blood sugar metabolism for chronic weight management, obesity-related conditions, and type 2 diabetes.
Sunitha Panthagada, M. Sivakumar
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

Analytical Quality by Design Approach of Reverse-Phase High-Performance Liquid Chromatography of Atorvastatin: Method Development, Optimization, Validation, and the Stability-Indicated Method

International Journal of Analytical Chemistry, 2021
The use of analytical quality by design (AQbD) approach in the optimization of the high-performance liquid chromatography (RP-HPLC) method is a novel tool.
Nabil K. Alruwaili
doaj   +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

Isolation, Identification, and Characterization of Forced Degradation Products of Bosentan by Using Advanced Analytical Techniques

SEPARATION SCIENCE PLUS, Volume 7, Issue 10, October 2024.
ABSTRACT The present study explains the degradation behavior of bosentan (BOS), active pharmaceutical ingredient (API) (BOS monohydrate), a Food and Drug Administration (FDA)–approved drug used for the treatment of chronic heart failure, subarachnoid hemorrhage, and Raynaud's syndrome pulmonary hypertension. The stress study was performed under various
Rajesh Kanagaddi, Satya Sree Nannapaneni, Jayaprakash Kanijam Raghupathi, Naresh Kumar Katari, Suresh Salakolusu, J. N. S. R. C. Murty, Mahesh Ranga, Muralidharan Kaliyaperumal   +7 more
wiley   +1 more source

Analytical quality by design (AQbD) assisted RP-HPLC technique for quantification of Picroside II in bulk and pharmaceutical dosage form

Future Journal of Pharmaceutical Sciences
Background Quality by design (QbD) adverts toward gaining of few expected quality with predetermined and desired specifications. Analytical quality by design (AQbD) approach toward the development of analytical method can significantly lead toward the ...
Sharib Raza Khan, Shailesh Dadge, Shivam Rathaur, Jiaur R. Gayen   +3 more
doaj   +1 more source

A sustainable AQbD-based UHPLC–MS/MS method for the determination of hallucinogenic phenethylamines in urine

Open Chemistry
A systematic Analytical Quality by Design (AQbD) approach was applied to the development and validation of a UHPLC–MS/MS method for the determination of hallucinogenic phenethylamine-derived novel psychoactive substances in urine. Owing to the continuous
Kostić Emilija, Milosavljević Biljana, Simić Jovana, Vujović Maja   +3 more
doaj   +1 more source

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