A newly developed and validated environmentally friendly RP-HPLC stability indicating method for the COVID-19 antiviral Molnupiravir: Application to degradation kinetics structure suggestion using LC-MS and the effect on viable cells of the major degradation products

Microchemical Journal, Journal Year: 2024, Volume and Issue: 199, P. 109980 - 109980

Published: Jan. 14, 2024

Language: Английский

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Greenness-integrated analytical quality by design-compliant development of a quasi-HDES-DLLME method for patent blue V preconcentration from various food products, and environmental water samples

Microchemical Journal, Journal Year: 2025, Volume and Issue: unknown, P. 113052 - 113052

Published: Feb. 1, 2025

Language: Английский

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Greenness-Integrated Analytical Quality by Design-Compliant Development of a Quasi-Hdes-Usa-Dllme Method for Patent Blue V Preconcentration from Various Food Products, and Environmental Water Samples

Published: Jan. 1, 2025

The global shift towards adopting White and Green analytical chemistry (WAC, GAC) principles reflects a growing commitment to sustainability across various scientific disciplines. This trend is parallel the recent release of ICH Q14 Q2(R2) guidelines, which promote implementation Analytical Quality by Design (AQbD) concepts into method development validation. Consequently, QbD has recently widened its domain over vast areas chemistry. In this context, present study introduces novel integration WAC GAC within AQbD workflow, for first time, developing quasi-hydrophobic deep eutectic solvent-based ultrasound-assisted dispersive liquid-liquid microextraction (Quasi-HDES-USA-DLLME) coupled with spectrophotometry determination patent blue V as model analyte. Herin, plan proposed method, we incorporated introduced Sample Preparation Metric Sustainability (SPMS) tool Efficient, Valid, (EVG) framework workflow. Where assurance both quality was built from outset, starting defining target profile (ATP) anticipated performance criteria greenness extraction efficiency. followed selecting appropriate technique procedure attributes (APAs). An early risk assessment (QRA) conducted using Ishikawa diagram identify parameters (APPs). scouting phase, solvent (DES) comprising tetrabutylammonium chloride (TBACl) n-decanoic acid (DA) in 1:3 ratio selected green efficient solvent, tetrahydrofuran serving an aprotic solvent. Subsequently, response surface methodology (RSM) Box-Behnken employed generate predictive mathematical models anticipating effects APPs on APAs. A second QRA leveraging Monte Carlo simulations delineated operable design region (MODR), zone assured less than 10 % failure. greenness-integrated, science-based approach enabled visualization well-defined 4D MODR, ensuring operational Ultimately, control strategy based SPMS EVG metrics implemented confirm these findings. most robust working point (RWP) established MODR identified follows: pH 4 (3.78-4.28), DES volume 401.5 µL (369.8-441.3 µL), THF 393.6µL (361.9-433.3 US time 9 min. (8.2-10 min.). validated according revised exhibiting quantitation limit 2 µg mL-1 detection 1.5 mL-1. Its reliability accuracy successful application PBV analysis food products, environmental water samples, underscoring versatility compliance standards.

Language: Английский

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COMPUTATIONAL MULTI-FACTOR MODELING TO THE SIMULTANEOUS DETERMINATION OF ASSAY AND RELATED SUBSTANCES METHOD DEVELOPMENT, VALIDATION, AND IDENTIFICATION OF MAJOR DEGRADATION PRODUCT OF COVID-19 DRUG MOLNUPIRAVIR BY HPLC: A STRATEGIC RESEARCH USING AQBD

International Journal of Applied Pharmaceutics, Journal Year: 2025, Volume and Issue: unknown, P. 204 - 224

Published: March 7, 2025

Objective: In the current study, a new approach was developed for simultaneous determination of molnupiravir with its degradation products using RP-HPLC by following Analytical Quality Design (AQbD) approach, proactive strategy advancing pharmaceutical research. Methods: Development carried out applying two levels fractional factorial design (2[5-1] Resolution: V, four center points, and no replicates) to five independent factors. The separation achieved liquid chromatography, equipped XBridge BEH Shield (250 mm x 4.6 mm, 3.5 µm) RP18 column at 260 nm gradient elution. A force study performed in different stressed conditions major degradant identified modern analytical techniques. Results: dependent factors were assessed against H-N plot, Pareto chart, 3D surface plot applied through ANOVA. Major obtained from stress characterized LC-MS, NMR, FTIR method found be specific, precise (% RSD ≤ 2.0), linear (r = 0.9999) accurate (99.2-101.4 %) 0.2-0.6 mg/ml range. LOD LOQ 0.02 % (0.08 µg/ml, S/N ratio ≥ 3) 0.05 (0.2 10, RSD: 2.2) respectively. solutions stable 48 hour clear glassware room temperature. depicts successful development validation assay related substances Experiments (DoE) approach. Conclusion: Fractional Factorial (FFD) experiment explored interactions Expert software, version 13.0. This AQbD-driven provided an in-depth understanding chromatographic factors, ensuring reliability effectiveness simultaneously determining purity impurity molnupiravir, assisting regulatory compliance.

Language: Английский

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Comprehensive Greenness, Blueness, and whiteness assessment of a sustainable RP-HPLC method for Atazanavir and Ritonavir with Forced degradation studies

Microchemical Journal, Journal Year: 2025, Volume and Issue: unknown, P. 114191 - 114191

Published: June 1, 2025

Language: Английский

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Experimental and theoretical study of the Favipiravir association in water solvent

Journal of Molecular Liquids, Journal Year: 2024, Volume and Issue: 401, P. 124603 - 124603

Published: March 29, 2024

Language: Английский

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