Results 51 to 60 of about 279 (161)

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

Development and Validation of Quality by Design‐Based HPLC Method for Impurity Profiling of Alprazolam

SEPARATION SCIENCE PLUS, Volume 8, Issue 10, October 2025.
ABSTRACT A quality by design (QbD)‐aided stability‐indicating method was developed for the simultaneous quantification of alprazolam and its four impurities using HPLC. The method was systematically optimized, followed by the establishment of a “method operable design region (MODR).” Critical parameters and ICH (Q14) emphasize the adherence to a “low ...
Mahesh Napa, Venkata Ratnam K., Venkata Nadh Ratnakaram, Sunil Dhuri, Bondigalla Ramachandra   +4 more
wiley   +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

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

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

Analytical Quality by Design (AQbD) for Quality and Risk Assessment of Pharmaceuticals to Immunomarkers

Journal of Pharmaceutical and Biopharmaceutical Research
Using advanced scientific and risk-based approaches for analytical methods offers significant benefits. Quality by Design (QbD) is a systematic framework that emphasizes understanding and controlling both product and process elements. Adhering to the principles outlined in the ICH guidelines can considerably improve the quality of drug substances ...
Vivekanandan Kalaiselvan, Meenakshi Dahiya, Gaurav Sanjay Mahalpure, Ritu Tiwari   +3 more
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

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

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