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
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]
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
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
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
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]
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]
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]
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]
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

