Development and application of ATR-FTIR spectroscopy for mixture homogeneity in pharmaceutical application
Penulis/Author
SYAIFUL CHOIRI (1); Prof. Dr. Teuku Nanda Saifullah Sulaiman, S.Si., M.Si., Apt. (2); Prof. Dr. Abdul Rohman, S.F., M.Si., Apt. (3)
Tanggal/Date
20 2020
Kata Kunci/Keyword
Abstrak/Abstract
Modified release formulation,however,the performance of dosage form not only depends on active pharmaceutical ingredient (API)distribution, but also excipient is a fundamentalkeyon this system.The objectiveof this research wasto applya simple and fast method on monitoring the API-excipient homogeneity using attenuated total reflectance (ATR) Fourier transform infrared(FTIR)spectroscopy in agastro-floating formulation.Gastro-floating formulation comprising metforminHCl, polymers, and effervescent componentswasblended in a cube mixer at several revolutions. At predetermined times, 50 mg of mixture was withdrawn in three different spots.ATRFTIR spectra acquisition was carried out from 4000to 650 cm-1at resolution of 2cm-1with 32 iterations. In order to minimize error, each samplewas analyzed quadruplicates.The homogeneity was depicted by a relative standard deviation of each sampling time.Specific vibration peaksthat hada good resolution and low interferenceeach otherwere selected to determine the response value. Vibration peaks at 3365,3148 and 937 cm-1;1730and 1051cm-1;and 1276cm-1wereassigned 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 systemfollowed 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 ofmetformin HCl gastro-floating formulationwas achieved by mixing of 15 min with 25 rpmwith lowest RSD of APIand excipients.
