PENGEMBANGAN DAN VALIDASI METODE PENETAPAN KADAR KETOKONAZOL MENGGUNAKAN FTIR

• Main Author: Najiyya, Amani
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/45442
• Institution: Institut Teknologi Bandung

Analytical method can be continually developed in line with the ever envolving technology so that it can achieve better results. Acceptance of an analytical method development depends on the results of the validation result of the respective method. Fourier Transform Infrared Spectroscopy (FTIR) is a technique widely used for identification and verification of functional groups in a compound. Ketoconazole is an antifungal drug derived from imidazole which is lipophilic, and used for systemic and superficial infections. Ketoconazole (KTZ) has a C-N group rarely owned by excipients contained by tablets; thus is expected to show a unique peak of spectrum for quantitative calculation basis of its level. The purpose of this study is to develop method of KTZ tablet assay using FTIR. Standard KTZ is mixed with KBr on various ratios and the FTIR spectrum is measured. Measured ketoconazole spectrum is initially converted into its form of absorbance then later the derivatization spectra is performed. Several number of wave providing clearly visible peaks are chosen and calculated its area under curve to be compared its linearity. The validation method conducted including the specificity, linearity, accuracy, precision, detection limits and quantitation limits as well as ranges. Once the method is validated, the testing on ketoconazole tablet samples on the market is conducted. Measurement is also performed if the simulation tablet extracted so that no matrix interference. Standard spectrum derivative of placebo with similar spectrum simulation tablet KTZ has spectrum derivative differ only in a range of wave number is the C-N group. Linearity test showed a linear result in the concentration range from 1.00 to 6.00 % w/w; the regression equation y = 0.1474x + 0.0020 and the correlation coefficient = 0.9995 and Vxo= 1.86 %. Recovery percentage is 100.49 to 100.95 %. Intraday precision on three different days and consecutive interday precision are 1.89; 1.68; 1.72; and 0.61%. Limits of detection and quantitation limit are 0.19 % and 0.66 % w/w. Assay of KTZ in the two sample tablet on the market with this method meets compendial requirements. Assay of KTZ in simulation tablet that is extracted first has recovery 95.73 %, it is mean that less accurate than directly assay. Assay of KTZ method by using FTIR with direct preparation has been validated which can be proposed as an alternative with some advantages that is easy, fast, accurate and do not use of solvents.