Results 41 to 50 of about 529 (166)

Analytical Quality by Design‐Based Stability‐Indicating UHPLC Method for Determination of Inavolisib in Bulk and Formulation

open access: yesSEPARATION 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

Clinical Presentation, Outcomes, and Treatment of Membranous Nephropathy after Transplantation

open access: yesInternational Journal of Nephrology, Volume 2018, Issue 1, 2018., 2018
There are scarce data about clinical presentation and outcomes of posttransplant membranous nephropathy (MN), and few reports include a large number of patients. This was a retrospective cohort including adult patients with posttransplant MN transplanted between 1983 and 2015 in a single center (n=41). Only patients with histological diagnosis of MN in
Artur Q. B. da Silva   +5 more
wiley   +1 more source

DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BENIDIPINE HYDROCHLORIDE BY USING QUALITY BY DESIGN (QbD) APPROACH [PDF]

open access: yes, 2018
Objective: To develop a simple, rapid, accurate, robust and inexpensive spectrophotometric method for the estimation of benidipine hydrochloride by using quality by design (QbD)†approach.Methods: A UV spectrophotometric method was developed on Shimadzu
Bishnoi, Ram Singh   +3 more
core   +3 more sources

Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing

open access: yesJournal of Chemistry, Volume 2015, Issue 1, 2015., 2015
Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT (Process Analytical Technology).
N. V. V. S. S. Raman   +3 more
wiley   +1 more source

Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

open access: yesInternational Journal of Analytical Chemistry, Volume 2015, Issue 1, 2015., 2015
Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design).
Ramalingam Peraman   +3 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

open access: yesSEPARATION 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-Assisted Development and Validation of RP-HPLC Method for Simultaneous Quantification of Remogliflozin Etabonate, Vildagliptin, and Metformin Hydrochloride in Single Formulation [PDF]

open access: yes
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

Partial least squares model inversion in the chromatographic determination of triazines in water [PDF]

open access: yes, 2021
Inside the framework of Analytical Quality by Design, a model-based approach has been developed and used to identify operating conditions (control method parameters) related to the composition and flow rate of the mobile phase for a liquid ...
Arce Antón, Mar   +8 more
core   +1 more source

Development and Validation of a Novel Isocratic RP-HPLC Method Using AQbD Approach for the Quantification of Favipiravir [PDF]

open access: yes
Background/Objectives: In this study, the analytical quality by design (AQbD) approach was used to develop an eco-friendly reversed-phase high-performance liquid chromatography (RP–HPLC) method to identify and quantify favipiravir (FAV).
Balogh György Tibor   +5 more
core   +1 more source

A Comprehensive Review on Analytical Method Development using RP-HPLC and Recent Advances in Pharmaceutical Applications [PDF]

open access: yes, 2023
The analytical technique of choice for separating, identifying, and quantifying complex mixtures is high-performance liquid chromatography (HPLC). Reverse-phase liquid chromatography (RP-HPLC) is the preferred separation mode for high-performance liquid ...
Baliyan, Vishal   +6 more
core   +2 more sources

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