A flow-injection biamperometric method for determination of pantoprazole (PTZ) in pharmaceutical tablets is reported for the first time. The reversible redox couples Fe3+/Fe2+, Fe(CN)6(3-)/Fe(CN)6(4-), Ce4+/Ce3+, VO3(-)NO2+, and I2/I- were tested as indicating redox systems for biamperometric determination of PTZ in a flow-injection assembly with optimized flow parameters. The best results were obtained using V03(-)NO2+, which showed to be a selective and sensitive biamperometric indicating system for PTZ even in the presence of excipients and antioxidants that typically are found in drugs. The analytical graph was linear (r = 0.99945) in the range from 10 to 100 mg/L using 25 mmol/L VO3(-) as the reagent and water as the carrier stream and applying 100 mV between the 2 platinum wire electrodes. The limits of detection and quantitation were 200 and 667 microg/L, respectively, with a sensibility of calibration of 22.6 mV/mg/L. The proposed method was successfully applied to determine PTZ in commercial pharmaceutical tablets with a mean relative error of 1.60% (n = 5) and mean relative standard deviation of 3.10%. Recoveries close to 100% showed good agreement between the expected amount of PTZ in tablets (40 mg) and the results found by the application of the proposed method and demonstrated that the formulations used in the tablet compositions do not interfere in the PTZ analysis. The system had good stability, with a relative standard deviation of 3.80% for 9 sequential injections of a 60 mg/L PTZ solution. A sampling rate of about 100 samples/h was obtained.
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Int J Pharm
January 2025
Department of Experimental Biology, Division of Genetics and Molecular Biology, Faculty of Science, Masaryk University, 611 37 Brno, Czech Republic. Electronic address:
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Pharmaceutical Engineering Research Group (PharmaEng), Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium. Electronic address:
The tablet diversion strategy, based on in-line near-infrared (NIR) tablet press feed frame measurements, can be a key component of both batch and continuous oral solid dose manufacturing processes. It enables real-time, high-frequency monitoring and control, enhancing process understanding and compliance compared to conventional interval-based sampling methods. Central to this strategy are NIR spectrometers, which serve as PAT systems for in-line blend uniformity monitoring in the feed of the tablet press.
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Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences and Center of Excellence for Innovation in Chemistry, Naresuan University, Phitsanulok 65000, Thailand.
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Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, Av. Prof. Lineu Prestes, 580 - Bloco 15, SP, São Paulo CEP 05508-000, Brazil. Electronic address:
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School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, IND.
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