Quality-by-design optimized RP-HPLC approach for the therapeutic drug monitoring of glibenclamide and fluoxetine in human plasma

Magdy, Galal; Al-enna, Amira A.; Belal, Fathalla; El-Domany, Ramadan A.; Abdel-Megied, Ahmed M.

doi:10.1016/j.microc.2024.110548

Microchemical Journal

2024

DOI: 10.1016/j.microc.2024.110548

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Quality-by-design optimized RP-HPLC approach for the therapeutic drug monitoring of glibenclamide and fluoxetine in human plasma

Galal Magdy,

Amira A. Al-enna,

Fathalla Belal

et al.

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Cited by 4 publications

References 37 publications

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An ultra‐fast green ultra‐high‐performance liquid chromatography‐tandem mass spectrometry method for estimating the in vitro metabolic stability of zotizalkib in human liver microsomes

Attwa,

Abdelhameed,

Kadi

2024

J of Separation Science

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Zotizalkib (ZTK, TPX‐0131) is a fourth‐generation highly effective inhibitor of wild‐type anaplastic lymphoma kinase (ALK) and ALK‐resistant mutations that can penetrate the central nervous system. It exhibited greater potency compared to all five officially approved ALK inhibitors. The aim of this study was to develop a rapid, accurate, eco‐friendly, and highly sensitive ultra‐high‐performance liquid chromatography‐tandem mass spectrometry (UHPLC‐MS/MS) method for measuring the concentration of ZTK in human liver microsomes (HLMs). The validation aspects of the current UHPLC‐MS/MS methodology in the HLMs were conducted in accordance with the bioanalytical method validation standards specified by the US Food and Drug Administration. ZTK and encorafenib were separated using an Agilent C8 column (Eclipse Plus) and an isocratic mobile phase. The calibration curve for the developed ZTK exhibited a linear relationship within the concentration range of 1–3000 ng/mL. The results from the Analytical Green‐ness Metric Approach program (0.76) suggested that the created method demonstrated a significant degree of environmental sustainability. The in vitro half‐life (t1/2) and intrinsic clearance (Clint) of ZTK were determined to be 15.79 min and 51.35 mL/min/kg, respectively that suggests the ZTK exhibits characteristics similar to those of a medication with a high extraction ratio. These approaches are crucial for the progress of novel pharmaceutical development, especially in improving metabolic stability.

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An ultra‐fast green ultra‐high‐performance liquid chromatography‐tandem mass spectrometry method for estimating the in vitro metabolic stability of zotizalkib in human liver microsomes

Attwa,

Abdelhameed,

Kadi

2024

J of Separation Science

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show abstract

A novel QbD HPLC approach for the concurrent analysis of amoxicillin, amprolium, and ethopabate in food samples and dosage forms

Magdy,

Ebrahim,

Belal

et al. 2024

Journal of Food Composition and Analysis

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A factorial-design/assisted HPLC method for simultaneous monitoring of phenytoin, trimethoprim, and sulphamethoxazole in plasma samples to optimize therapy and mitigate toxicity risks

El Sharkasy,

Aboshabana,

Tolba

et al. 2024

Microchemical Journal

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Quality-by-design optimized RP-HPLC approach for the therapeutic drug monitoring of glibenclamide and fluoxetine in human plasma

Cited by 4 publications

References 37 publications

An ultra‐fast green ultra‐high‐performance liquid chromatography‐tandem mass spectrometry method for estimating the in vitro metabolic stability of zotizalkib in human liver microsomes

An ultra‐fast green ultra‐high‐performance liquid chromatography‐tandem mass spectrometry method for estimating the in vitro metabolic stability of zotizalkib in human liver microsomes

A novel QbD HPLC approach for the concurrent analysis of amoxicillin, amprolium, and ethopabate in food samples and dosage forms

A factorial-design/assisted HPLC method for simultaneous monitoring of phenytoin, trimethoprim, and sulphamethoxazole in plasma samples to optimize therapy and mitigate toxicity risks

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