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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
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0975-2366
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Development and application of ATR-FTIR spectroscopy for mixture homogeneity in pharmaceutical application
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Development and application of ATR-FTIR spectroscopy for mixture homogeneity in pharmaceutical application

Author: SYAIFUL CHOIRI, TEUKU NANDA SAIFULLAH SULAIMAN, ABDUL ROHMAN
Abstract: Modified release formulation, however, the performance of dosage form not only depends on active pharmaceutical ingredient (API) distribution, but also excipient is a fundamental key on this system. The objective of this research was to apply a simple and fast method on monitoring the API-excipient homogeneity using attenuated total reflectance (ATR) Fourier transform infrared (FTIR) spectroscopy in a gastro-floating formulation. Gastro-floating formulation comprising metformin HCl, polymers, and effervescent components was blended in a cube mixer at several revolutions. At predetermined times, 50 mg of mixture was withdrawn in three different spots. ATR FTIR spectra acquisition was carried out from 4000 to 650 cm-1 at resolution of 2 cm-1 with 32 iterations. In order to minimize error, each sample was analyzed quadruplicates. The homogeneity was depicted by a relative standard deviation of each sampling time. Specific vibration peaks that had a good resolution and low interference each other were selected to determine the response value. Vibration peaks at 3365, 3148 and 937 cm-1;1730 and 1051 cm-1; and 1276 cm-1 were assigned as metformin HCl, polymers, and sodium bicarbonate quantification peaks, respectively. The RSD of API and excipients showed a quadratic curve. Thereby, it confirmed that the blending system followed a random mixing process. The ATR-FTIR technique was successfully applied in the monitoring of API-excipient distribution in the gastro-floating formulation. The homogeneity of metformin HCl gastro-floating formulation was achieved by mixing of 15 min with 25 rpm with lowest RSD of API and excipients.
Keyword: ATR-FTIR, mixture homogeneity, gastro-floating formulation, mixing process
DOI: https://doi.org/10.31838/ijpr/2020.12.04.003
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