DEVELOPMENT AND VALIDATION METHOD OF DETERMINATION OF TRANEXAMIC ACID LEVELS IN TABLET BY FTIR AND COMPARATION WITH SPECTROPHOTOMETRY VISIBLE

• Main Author: Nur Auli, Winni
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/44342
• Institution: Institut Teknologi Bandung

Tranexamic acid is an antifibrinolytic drug that inhibits the breakdown of fibrin clots. A specific, simple, and rapid method of determination tranexamic acid levels has been developed using FTIR and the comparison will be analyzed using spectrophotometry visible. Correlations between the two were analyzed using t-test. The development of the method start by making the calibration curve of a series concentrations of the active ingredient, the material mixed with KBr, to be measured using FTIR. The spectrum is altered into the absorbance form and then derivatized. Concentration range of 0.5-1.75%w/w at wave number 1511.08-1573.63 cm -1 which is group NH shows difference and linearity. The method was linear with regression y=1.3568x-0.0041, correlation coefficient (r) = 0.9994 and Vx0 = 1.5802%. Recovery of tranexamic acid was 98.95%, 100.013%, 100.017%. Intraday and interday precision is shown by SBR 1.95%, 1.49%, 1.33% and 1.55%. LOD and LOQ of the method is 0.0531% w/w and 0.1770%w/w. This method has met the requirements of validation. This method were compared with visible light spectrophotometry methods using ninhydrin as derivating agents at concentrations of 3-25?g/mL at 559nm. The method was linear the with regression y=0.0336x+0.1087, correlation coefficient (r) = 0.9992 and Vx0 = 0.5307%. Recovery of tranexamic acid was 99.246%, 101.355%, 101.432%. Intraday and interday precision is shown by SBR 1.183%, 0.884%, 0.279% and 0.239%, 1.224%, 1.319%. LOD and LOQ of the method is 0.7345 %w/w and 2.448 %w/w. Determination of tranexamic acid in commercial products has met the requirements of content in compendial. The t-test shows no significant difference between these two methods. FTIR method has advantages such as easier, simpler, faster and cheaper than visible light spectrophotometry method.