Results 61 to 70 of about 796 (185)

A novel quality by design approach for developing an HPLC method to analyze herbal extracts: A case study of sugar content analysis.

PLoS ONE, 2018
The aim of this study was to present a novel analytical quality by design (AQbD) approach for developing an HPLC method to analyze herbal extracts.
Jingyuan Shao, Wen Cao, Haibin Qu, Jianyang Pan, Xingchu Gong   +4 more
doaj   +1 more source

Constraints on Modified Gravity Models from White Dwarfs

, 2017
Modified gravity theories can introduce modifications to the Poisson equation in the Newtonian limit. As a result, we expect to see interesting features of these modifications inside stellar objects.
Banerjee, Srimanta, Shankar, Swapnil, Singh, Tejinder P.   +2 more
core   +1 more source

Analytical quality by design using a D-optimal design and parallel factor analysis in an automatic solid phase extraction system coupled to liquid chromatography. Determination of nine PAHs in coffee samples [PDF]

, 2023
Optimizing a multi-residue analysis when using an automatic SPE (solid phase extraction) system and complex matrices becomes a difficult problem because of the large number of experimental factors that can influence the recovery of the analytes ...
Arce Antón, Mar, Ortiz Fernández, Mª Cruz, Sarabia Peinador, Luis Antonio, Valverde Som, Lucía   +3 more
core   +1 more source

Sustainable RP‐HPLC Approach for Profiling Pioglitazone and Related Substances

Journal of Chemistry, Volume 2026, Issue 1, 2026.
A sustainable RP‐HPLC method for the comprehensive fingerprinting of pioglitazone and its related substances was developed and validated in alignment with green analytical chemistry principles. Utilizing eco‐friendly solvents and reducing waste generation were used to optimize chromatographic conditions.
Tahani Y. A. Alanazi, Samar M. Mahgoub, Fahad M. Alminderej, Yasmeen G. Abou El-Reash, Omkulthom Al kamaly, Sayed M. Saleh, Mahmoud A. Mohamed, Munmun Bardhan   +7 more
wiley   +1 more source

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

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

A systematic AQbD approach for optimization of the most influential experimental parameters on analysis of fish spoilage-related volatile amines [PDF]

, 2020
The volatile amines trimethylamine (TMA) and dimethylamine (DMA) could be used as important spoilage indices for seafood products, assisting in the determination of the rejection period.
Câmara, José S., Freitas, Jorge, Silva, Pedro, Vaz-Pires, Paulo   +3 more
core   +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 Development and Validation of RP-HPLC Method for Simultaneous Quantification of Remogliflozin Etabonate, Vildagliptin, and Metformin Hydrochloride in Single Formulation [PDF]

Introduction:The study aimed to optimize and validate a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous quantification of Remogliflozin Etabonate (REM), Vildagliptin (VIL), and Metformin Hydrochloride (MET) in a
Jigar A. Shah, Dr. B.N. Suhagia
core   +2 more sources