Results 51 to 60 of about 325 (160)

Optimization of green LC-MS method for rosuvastatin and teneligliptin using AQbD chemometric approach

Journal of Applied Pharmaceutical Research
Background: Rosuvastatin combined with Teneligliptin formulation is commonly used in the treatment of Diabetic dyslipidaemia. However, only a few analytical methods have been published for the examination of this drug in a synthetic mixture or in a ...
S R Aswathy, Hemnath Elango
doaj   +1 more source

AQbD enabled optimization of RP-HPLC method for the estimation of pioglitazone and vildagliptin and its forced degradation studies

Journal of Applied Pharmaceutical Research
Background: Diabetes mellitus is a metabolic disorder that is managed with combination therapy. Pioglitazone improves insulin sensitivity by activating PPAR-γ, whereas vildagliptin increases incretin activity by inhibiting DPP-4.
P V Devi Swapna, G. Saravanan
doaj   +1 more source

Chromatographic study of sitagliptin and ertugliflozin under quality-by-design paradigm

Brazilian Journal of Pharmaceutical Sciences, 2023
The present study entails the systematic development and validation of a stability-indicating RP-HPLC method for the analysis of sitagliptin and ertugliflozin in a fixed-dose combination.
Sunitha Gurrala, Shivaraj , Panikumar Durga Anumolu, Haripriya D, Subrahmanyam CVS   +4 more
doaj   +1 more source

Sustainable Ethanol‐Based Reversed‐Phase Liquid Chromatography for Determination of Diltiazem pKa and Quantification with Integrated Green and White Analytical Metrics

ChemistryOpen, Volume 15, Issue 5, May 2026.
A sustainable reversed‐phase liquid chromatography method is developed for diltiazem analysis and pKadetermination. The study integrates green and white analytical chemistry frameworks to evaluate environmental impact and practicality. The Environmental, Performance, and Practicality Index is utilized as a comprehensive, holistic tool for the ...
Zehra Üstün, İlkay Konçe, Ebru Çubuk Demiralay   +2 more
wiley   +1 more source

Software-assisted analytical Quality by Design for stability-indicating method development: integration of DoE and predictive retention modeling using MODDE® and DryLab® [PDF]

Makedonsko Farmacevtski Bilten
In modern pharmaceutical development, the increasing complexity of drug substances, formulations, and regulatory expectations has rendered traditional one-factor-at-a-time (OFAT) approaches to analytical method development inefficient and increasingly ...
Dino Karpicarov, Ivana Mitrevska, Blagica Manchevska, Paulina Apostolova, Jasmina Tonic Ribarska, Biljana Gjorgjeska   +5 more
doaj   +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

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

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