DEVELOPMENT AND VALIDATION OF SPECTROFLUOROMETRIC METHOD FOR THE DETERMINATION OF ACETYLCYSTEINE BY USING CERIUM (IV) SULFATE

• Main Author: Ramadhian Mangantjo, Nauval
• Format: Final Project
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/72164
• Institution: Institut Teknologi Bandung

N-acetylcysteine (NAC) is a mucolytic drug used for respiratory diseases that is available in the forms of capsules, film-coated tablets, granules, dry syrup, and effervescent tablets. Measurement of acetylcysteine needs to be done to ensure the quality of the drug. This research has a purpose to develop and validate a fluorimetric method using Ce(IV) sulfate reagent for the measurement of acetylcysteine. This method is based on the redox reaction between acetylcysteine and Ce (IV) in an acidic medium to produce Ce (III) which can fluoresce. Based on the optimization of the method, the best reaction conditions were when using 0.05 M H2SO4, an acetate buffer pH 4.5, and a reaction temperature of 50 oC for 2 hours. The intensity of the reaction product was measured at the excitation and emission wavelengths of 259 nm and 347 nm, respectively. This method had outstanding specificity because other components in the sample matrix did not interfere with the analysis. The method has good linearity in the concentration range of acetylcysteine 1.299 ppm - 5.196 ppm with a linear regression equation y = 42587x - 17127 and a correlation coefficient (R) of 0.9998 and a linear regression coefficient of variance (Vxo) of 0.949 %. This method has a limit of detection (LOD) of 0.102 ppm, and a limit of quantitation (LOQ) of 0.308 ppm. The method accuracy test shows the percentage of recovery in the range of 98.218 - 101.774 %. Meanwhile, the precision test on the same day (intraday) obtained the relative standard deviation in the range of 0.937 - 1.913 % and the precision test on a different day (interday) obtained it in the range of 0.806 -1.601 %. The developed fluorimetric method complied with the method validation requirements and can be used to analyze acetylcysteine in capsules and effervescent tablets.