PENGEMBANGAN DAN VALIDASI METODE PENETAPAN KADAR RANITIDIN HIDROKLORIDA DALAM SEDIAAN TABLET MENGGUNAKAN FOURIER-TRANSFORM INFRARED (FTIR)

• Main Author: Qalbi Imani Antadiredja, Zahra
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/44949
• Institution: Institut Teknologi Bandung

Assay of active substance is necessary to guarantee the quality of the drug. FTIR is a method for identifying and characterizing chemical compounds. Ranitidine HCl is a histamine H2 receptor antagonist for the treatment of stomach and duodenal ulcers by reducing gastric acid secretion. Ranitidine HCl has the N-H group which can show a typical spectrum when ranitidine HCl in the tablet dosage form. The purpose of this study is developing FTIR method so it can be used for ranitidine HCl assay. Standard ranitidine HCl was mixed with KBr in various ratios and the FTIR spectrum was measured. The measured spectrum of ranitidine HCl was converted into its form of absorbance afterwards the derivatization was performed. Two wavenumber had a clear and specific peak was selected and then the area under the curve was calculated. The validation method included specificity, linearity, accuracy, precision, detection limit, quantitation limit, and ranges. Once the method was validated, testing levels of ranitidine HCl in the tablet samples from generic drugs and branded-name drugs from the market was conducted. The derivatives spectra of matrixes and derivative spectra of ranitidine HCl simulation tablets had a different spectrum in the range of wavenumbers owned by N-H group that was 1573.63 –1523.49 cm- 1 . Validation test showed a linear concentration range from 1.00 to 3.50% w/w; the regression equation y = 0.14x + 0.0261; the correlation coefficient = 0.9993; and showed the VXO = 1.66%. Percent recovery was 98.99 to 100.40%. Intra-day and inter-day precisions respectively were 1.93; 1.75; 1.67; dan 1.43%. The LOD and LOQ were 0.11 and 0.37% w/w. Levels of ranitidine HCl in the tablet samples from generic drugs and branded-name drugs had met compendia requirements. Analysis method using FTIR could be used for ranitidine HCl assay.