A QbD-based stability-indicating RP-HPLC method for larotrectinib: degradation kinetics and integrated white, green, and blue analytical assessment [PDF]
Background: Larotrectinib, a selective TRK inhibitor, received FDA approval on April 10, 2025, for treating solid tumors with NTRK gene fusions. Despite its therapeutic significance, no RP-HPLC method using a Quality-by-Design (QbD) framework has been ...
Adikay, Sreedevi, P. N. S, Syamala
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Optimization of green LC-MS method for rosuvastatin and teneligliptin using AQbD chemometric approach [PDF]
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 ...
Hemnath Elango, S R Aswathy
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Ion-pair RP-HPLC strategy for resolving polarity-mismatched APIs in sustained-release capsules: an AQbD-driven mechanistic and statistical optimization [PDF]
A robust ion-pair reversed-phase HPLC (RP-HPLC) method was developed for the simultaneous separation of pseudoephedrine sulfate (PSE) and loratadine (LOR) in sustained-release capsules.
Leo Anggara, Satrialdi, Sophi Damayanti
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Chemometric Approaches for Sustainable Pharmaceutical Analysis Using Liquid Chromatography [PDF]
Chemometrics, which applies mathematical and statistical methods to aid in experimental design, data analysis, and process optimization, is gaining more importance.
Aboushady, Dina +6 more
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HOLISTIC APPLICATION OF QUALITY BY DESIGN (QbD) FOR PHARMA PRODUCT DEVELOPMENT EXCELLENCE AND REGULATORY COMPLIANCE [PDF]
The realm of optimizing the drug formulations has gained significant momentum towards more systematic approach of “Quality by Design (QbD)” based strategies employing “Design of Experiments (DoE)” from the erstwhile traditional short-gun approach of ...
Beg, Sarwar +4 more
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Ultrasound-Assisted Extraction- and Liquid Chromatography-Based Method Development and Validation for Obtaining and Qualitative Determination of Apple Pomace Three Triterpene Acids using Analytical Quality by Design [PDF]
Background: Apple pomace has garnered significant attention within the life sciences domain due to its underutilized status as a waste material from apple processing.
Chkhaidze, Mariam +3 more
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Analytical Quality by Design Driven Development and Validation of UV-Visible Spectrophotometric Method for Quantification of Xanthohumol in Bulk and Solid Lipid Nanoparticles. [PDF]
Turk J Pharm Sci, 2023 Vancha H +6 more
europepmc +1 more source
Eco-conscious AQbD-guided stability-indicating RP-UPLC method for analysing Tovorafenib in bulk and dosage forms. [PDF]
Sci RepGoud VM +6 more
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Development of Analytical Quality by Design Compliant Chaotropic Chromatography Method for Ziprasidone and Its Five Impurities Determination. [PDF]
Pharmaceuticals (Basel), 2023 Rmandić M +6 more
europepmc +1 more source