Results 131 to 140 of about 1,038 (200)

Reverse Phase High Performance Liquid Chromatography Method for the Estimation of Mangiferin in Nano Formulations: Development and Optimization by Analytical Quality-by-Design. [PDF]

ACS Omega
Kamath AP, Kumar L, Mutalik S, Nayak PG, Nandakumar K.   +4 more
europepmc   +1 more source

Green UHPLC approach for the quantitative determination of tiopronin residues in cleaning validation processes. [PDF]

BMC Chem
Gohel J, Patel A, Kotadiya R.
europepmc   +1 more source

Comparative AI-optimized HPLC-DAD strategy for the simultaneous determination of ranolazine, amlodipine, and diltiazem with pharmacotherapeutic relevance and multi-trait sustainability assessment. [PDF]

Sci Rep
Aboras SI, Korany MA, Yehia RA, Ragab MAA.   +3 more
europepmc   +1 more source

STRATEGIC IMPLEMENTATION OF ANALYTICAL QUALITY BY DESIGN (AQbD) IN HPLC METHOD DEVELOPMENT FOR PHARMACEUTICAL QUALITY ASSURANCE: A COMPREHENSIVE REVIEW

The pharmaceutical sector is witnessing a fundamental transition from empirical "One- Factor-At-A-Time" (OFAT) methodologies toward the highly structured "Analytical Quality by Design" (AQbD) paradigm. This review aims to critically evaluate how AQbD enhances the robustness and reliability of High-Performance Liquid Chromatography (HPLC) methods ...
openaire   +1 more source

Implementation of the QbD Approach to the Analytical Method Development and Validation for the Estimation of the Treprostinil Injection Dosage Form by RP-HPLC. [PDF]

ACS Omega
Alluri NR, Bandlamudi MR, Kuppusamy S, Morais SR.   +3 more
europepmc   +1 more source

Designing Quality: Quality by Design in the analytical pharmaceutical development. [PDF]

, 2018
Nompari, Luca
core  

Breakthrough RP-HPLC strategy for synchronous analysis of pyridine and its degradation products in powder for injection using quality metrics. [PDF]

Sci Rep
Al-Wasidi AS, Katamesh NS, Alminderej FM, Saleh SM, Ahmed HA, Mohamed MA.   +5 more
europepmc   +1 more source

Analytical quality by design-based development of a capillary electrophoresis method for Omeprazole impurity profiling [PDF]

Furlanetto, S., Marzullo, L., Orlandini, S.   +2 more
core   +1 more source

RP-DAD-HPLC Method for Quantitative Analysis of Clofazimine and Pyrazinamide for Inclusion in Fixed-Dose Combination Topical Drug Delivery System. [PDF]

Methods Protoc
Brits M, Bouwer F, Viljoen JM.
europepmc   +1 more source

ANALYTICAL QUALITY BY DESIGN (AQBD) IN THE DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC METHODS FOR FIXED-DOSE COMBINATIONS: A COMPREHENSIVE REVIEW

The paradigm of pharmaceutical analysis is undergoing a critical transition from traditional empirical Quality by Testing (QbT) frameworks to systematic, risk-based methodologies encapsulated by the Analytical Quality by Design (AQbD) initiative. This shift is particularly crucial for Fixed-Dose Combinations (FDCs), where the simultaneous estimation of
openaire   +1 more source