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
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A Survey on the Implementation of Analytical Quality by Design in Method Development in the Pharmaceutical Industries of Southeast Brazil: Challenges and Opportunities. [PDF]
Claro BC, Condado EF, Prado LD.
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Development of an AQbD-guided sustainable RP-HPLC method for simultaneous quantification of saracatinib and rapamycin in lipid-polymer hybrid nanocarriers. [PDF]
Angolkar M +8 more
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Implementation of QbD Approach to the Analytical Method Development and Validation for the Estimation of Arformoterol Tartrate Inhalation Solution Dosage Form via RP-HPLC. [PDF]
Alluri NR +3 more
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From design space to green space: an analytical quality by design-assisted high-performance liquid chromatography method for the quantification of triple-combination antihypertensive drugs. [PDF]
Yenduri S, Yogaraj P, Koppuravuri NP.
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Analytical Quality-by-Design-Based Chaotropic Chromatography Method for the Determination of Bupropion and Its Impurities [PDF]
A novel chaotropic chromatography method, developed using Analytical Quality-by-Design (AQbD) principles, is presented for the quantitative determination of bupropion and its impurities.
Yannis, Dotsikas +2 more
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Green RP-HPLC method for estimation of trigonelline: AQbD based development, validation, and application to nanoformulations. [PDF]
Kothapalli P, Vasanthan M.
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Reverse Phase High Performance Liquid Chromatography Method for the Estimation of Mangiferin in Nano Formulations: Development and Optimization by Analytical Quality-by-Design. [PDF]
Kamath AP +4 more
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DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING HPTLC METHOD FOR VERAPAMIL ANALYSIS USING THE AQBD APPROACH [PDF]
Objective: To develop selective, precise and accurate High Performance Thin Layer Chromatography (HPTLC) method for forced degradation study of Verapamil by implementing AQbD (Analytical quality by design) approach. To optimize chromatographic conditions
PRAJAPATI, DHRUVI, BADGUJAR, GAYATRI S.
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