Results 51 to 60 of about 329 (162)

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

Multivariate optimization and evaluation of quaternary mixture in bulk and co-formulated dosage forms by central composite design

Future Journal of Pharmaceutical Sciences, 2021
Background The current study describes the use of central composite design for multivariate optimization of resolution and retention time, taking into account different critical method parameters like organic phase, pH, flow rate, and wavelength for risk
Rama Tulasi Jampana, Prameela Rani Avula, Panikumar Durga Anumolu   +2 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

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

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 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

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