Results 41 to 50 of about 62,955,482 (158)

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

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

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

AQbD-novel strategy for analytical methods

Background Analytical Quality by Design (AQbD) has emerged as a pivotal paradigm in the realm of analytical chemistry, revolutionizing the approach to method development and validation. This innovative strategy integrates principles of Quality by Design (
Hemant Chikhale, Rutuja Kothrukar, Amruta Bairagi, Laxmikant Borse, Sreya Kosanam   +4 more
core   +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

ANALYTICAL QUALITY BY DESIGN (AQBD)-BASED DEVELOPMENT AND VALIDATION OF A ROBUST RP-HPLC METHOD FOR THE QUANTITATIVE ESTIMATION OF EMPAGLIFLOZIN IN PHARMACEUTICAL DOSAGE FORMS

Background: Empagliflozin, a selective sodium-glucose co-transporter-2 (SGLT2) inhibitor, is widely prescribed for the management of type 2 diabetes mellitus and has demonstrated significant cardiovascular and renal protective effects.
Omprakash Goshain, Aabhash Singh, Anjali Bhardwaj   +2 more
core   +1 more source

Green RP‐UPLC Method for Simultaneous Determination of Cyclopentolate and Organic Impurities Using DoE and Sustainability Metrics

International Journal of Analytical Chemistry, Volume 2025, Issue 1, 2025.
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 ...
Bandar R. Alsehli, Abdullah H. Alluhayb, Lateefa A. Al-Khateeb, Sayed M. Saleh, Ammena Y. Binsaleh, Mahmoud A. Mohamed, Mahmood Ahmed   +6 more
wiley   +1 more source

Development of a colorimetric method for determination of neomycin sulphate using the concepts of quality by analytical design (AQbD)

, 2019
Para efetivamente tratar uma infecção, é necessário que o antibiótico possua atividade antimicrobiana adequada e seja capaz de inibir o crescimento do microrganismo patogênico.
Patricia Cristina de Santana, Santana, Patricia Cristina de   +1 more
core   +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

Quantification of menthol by gas chromatography (GC) based on the in-house standard method and driven by an analytical quality by design (AQbD) approach.

, 2023
Se presenta un enfoque de Calidad Analítica por Diseño (AQbD) con la finalidad de establecer los parámetros para cuantificar e identificar el mentol utilizando un método analítico reproducible, empleando cromatografía de gases y estándar interno.
Puentes Fonseca, Santiago, Puentes Torres, Julian Mauricio   +1 more
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