|
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 At predetermined times, 50 mg of mixture was withdrawn in three different spots.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
|
| EOI:
|
-
|
| DOI:
|
https://doi.org/10.31838/ijpr/2020.12.04.003
|
| Download:
|
Request For Article
|
|
|