PENGEMBANGAN DAN VALIDASI METODE FTIR DIBANDINGKAN TERHADAP METODE SPEKTROFOTOMETRI SINAR TAMPAK PADA PENETAPAN KADAR SEDIAAN INJEKSI ANTIBIOTIK KANAMISIN SULFAT

• Main Author: Fauzia N A, Rizka
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/44404
• Institution: Institut Teknologi Bandung

Kanamycin sulfate is an aminoglycoside antibiotic used to treat various infection especially tuberculosis. Determination of active compound in dosage form is needed to meet efficacy, safety, and quality demands. The purpose of this study was to develop FTIR method based on kanamycin sulfate specific spectrum and then this method was compared to visible spectrophotometry method. FTIR method validation was performed with the determination of validation parameters such as specificity, linearity, accuracy, precision, range, limit of detection (LOD), and limit of quantification (LOQ). The results showed that kanamycin sulfate gave linearity in the range 0,25 – 1,5% with coefficient of correlation 0,99975. Recovery was 99,18 - 100,27%, intraday and interday precision were 1,14%; 0,69%; 0,76%; and 0,33%. LOD and LOQ were 0,04% and 0,12%. The validated method was used to determine the content of kanamycin sulfate in the commercial injection form and the result met the compendial requirement. Visible spectrophotometry method was verified by determination of verification parameters such as linearity, accuracy, precision, range, LOD, and LOQ in maximum absorbance wavelength 564 nm. The verified method was used to determine the content of kanamycin sulfate in the commercial injection form and the result met the compendial requirement. There were no meaningful differences between the determination of kanamycin sulfate in injection form obtained from FTIR method with the determination obtained from visible spectrophotometry method. Both of the methods could be used as alternative methods for determination of kanamycin sulfate in injection form with the advantages in FTIR method which are faster, simpler, and more affordable.