Results 81 to 90 of about 1,038 (200)

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

, 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, Jain, C. P., Kumar, Manish, Shukla, Ajay Kumar   +3 more
core   +3 more sources

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

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

, 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, Kumar, Amrendra, Kumar, Deepak, Kumar, Nitish, Kumar, Vinay, Rai, Raja Ram Mohan, Raj, Arjesh   +6 more
core   +2 more sources

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 sustainable AQbD-based UHPLC–MS/MS method for the determination of hallucinogenic phenethylamines in urine

Open Chemistry
A systematic Analytical Quality by Design (AQbD) approach was applied to the development and validation of a UHPLC–MS/MS method for the determination of hallucinogenic phenethylamine-derived novel psychoactive substances in urine. Owing to the continuous
Kostić Emilija, Milosavljević Biljana, Simić Jovana, Vujović Maja   +3 more
doaj   +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

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

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

, 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, Herrero Gutiérrez, Ana, Ortiz Fernández, Mª Cruz, Reguera Alonso, Celia, Ruiz Miguel, Santiago, Sanllorente Méndez, Silvia, Sarabia Peinador, Luis Antonio, Sánchez Pastor, Mª Sagrario, Valencia García, Olga   +8 more
core   +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

Model inversion and three-way decompositions in the analytical quality by design strategy for the determination of phthalates BY HS-SPME-GC-MS [PDF]

In this work, strategies within Analytical Quality by Design (AQbD) with tools of the Process Analytical Technology (PAT) were used in the development of a head space-solid phase microextraction-gas chromatography-mass spectrometry (HS-SPME-GC-MS ...
Herrero Gutiérrez, Ana, Ortiz Fernández, Mª Cruz, Reguera Alonso, Celia, Sarabia Peinador, Luis Antonio, Sánchez Pastor, Mª Sagrario, Valverde Som, Lucía   +5 more
core   +1 more source