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المؤلفPrajapati, Pintu
المؤلفArdeshana, Princy
المؤلفKansara, Yashwini
المؤلفShah, Pranav
المؤلفPulusu, Veera Shakar
المؤلفHaque, Anzarul
المؤلفKalam, Mohd Abul
المؤلفShah, Shailesh
تاريخ الإتاحة2025-05-29T05:34:47Z
تاريخ النشر2025-05-31
اسم المنشورAnalytical Biochemistry
المعرّفhttp://dx.doi.org/10.1016/j.ab.2025.115785
الرقم المعياري الدولي للكتاب00032697
معرّف المصادر الموحدhttps://www.sciencedirect.com/science/article/pii/S0003269725000223
معرّف المصادر الموحدhttp://hdl.handle.net/10576/65313
الملخصThis study developed a microwave-aided spectrofluorimetric method for in-vivo characterizing teneligliptin-loaded solid dispersion adsorbate (TNG-SDA) using a quality by design approach. The microwave-aided chemical reaction was applied for derivatization of non-fluorescent teneligliptin with NBD-Cl (7-chloro-4-nitrobenzoxadiazole). TNG-SDA was prepared to enhance the solubility and bioavailability of teneligliptin, a BCS (Biopharmaceutical Classification System) class II drug. The method utilized environmentally friendly solvents and employed analytical quality by design principles for optimization. Critical method parameters were identified through failure mode impact analysis and optimized using response surface modelling. The fluorescence spectra of teneligliptin exhibited linearity across the concentration range of 50–250 ng/mL, with a correlation coefficient of 0.9978. The developed method was found to be accurate, precise, robust, specific and sensitive for estimation of teneligliptin. The method was applied to evaluate in vitro dissolution, pharmacokinetics, and pharmacodynamic of TNG-SDA compared to commercial formulations. Results showed significant improvements in teneligliptin solubility and bioavailability with the developed SDA. The microwave-aided derivatized fluorescent product was characterized by mass spectrometry. The method demonstrated environmental sustainability, robustness, sensitivity, cost-effectiveness, and user-friendliness when evaluated using white analytical chemistry approaches. It provided a sensitive and green alternative to existing hyphenated techniques for nanogram-level teneligliptin detection in pharmacokinetic studies.
راعي المشروعThe authors of this publication would like to thank the director of Maliba Pharmacy College for providing the necessary facilities and equipment for this study. The authors extend their appreciation to the Researchers Supporting Project number (RSPD2025R726), King Saud University, Riyadh, Saudi Arabia.
اللغةen
الناشرElsevier
الموضوعTeneligliptin
Solid dispersion adsorbate
Quality by design approach
White analytical chemistry
Mass spectrometry
العنوانIn-vivo microwave-aided spectrofluorimetric characterization of teneligliptin-loaded solid dispersion adsorbate using quality by design approach
النوعArticle
رقم المجلد700
ESSN1096-0309
dc.accessType Full Text


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