METHOD VALIDATION FOR SIMETHICONE ANALYSIS ON PANCREOFLAT TABLET USING INFRARED SPECTROSCOPY

• Main Author: Virdilia, Carolina
• Format: Final Project
• Language: Indonesia
• Subjects: Kimia
• Online Access: https://digilib.itb.ac.id/gdl/view/73074
• Institution: Institut Teknologi Bandung

Simethicone is a component in pancreoflat, which functions to reduce bloating or pain in the stomach due to excessive gas. Simethicone levels need to be analyzed for levels to ensure the quality of the drug being produced and consumed. This study aims to validate the simethicone analysis method in pancreoflate using infrared spectroscopy. Simethicone was extracted using toluene from the tablet which was dissolved in NaOH solution. The validation method includes linearity, accuracy, precision, limit of detection and limit of quantification using Fourier transform infrared (FTIR) spectroscopy in the wave number range of 1150-1350 cm-1. Based on the research that has been done, the simethicone analysis method on pancreoflat tablets using FTIR has a good validation value and meets the validation test requirements with a correlation coefficient (r2) corrected absorption peak (base line 1201-1301 cm-1) at 1261 cm-1 is 0.9978 for the concentration range of 60-140 mg/825 mg of sample. The detection limit and quantification limit values were 0.0887/825 mg sample and 0.2688 mg/825 mg sample, respectively. Recovery ?99.0 and RSD value <2.5 %.