Penetapan Kadar Campuran Parasetamol Dan Tramadol HCl Dalam Tablet Dengan Metode Kemometrik Dan Rasio Absorbansi Secara Spektrofotometri Fourier Transform Infrared

Abstract

Fixed-dose combinations of paracetamol and tramadol HCl are effective in the treatment of moderate to severe pain. Therefore, the determination of the levels of the mixture of paracetamol and tramadol HCl is very important for the pharmaceutical industry. The purpose of this study was to determine the levels of paracetamol and tramadol HCl mixture in tablet S and tablet A using partial least square (PLS) chemometric and absorbance ratio methods by Fourier Transform Infrared This study was conducted by making a calibration model and chemometrically validating each of the five concentrations measured absorbance at the wave numbers of paracetamol and tramadol HCl, namely 1265,30-1199,72cm-1 and 1321,24-1255,66cm-1 and the wave number of isoabsorptive point at 3315,63cm-1. Then the results of R2, PRESS and RMSECV, accuracy, precision, LOD and LOQ were evaluated. The results of the study with the PLS chemometric method of paracetamol and tramadol HCl with RMSECV values of 0,06279 and 0,03785, PRESS values of 0,02366 and 0,00860, and R2 values of 0,9995 and 0,9998, respectively, while the absorbance ratio method obtained relative standard deviation values for paracetamol and tramadol HCl of 0.6910% and 0,9163% for Tablet S and 0,9857% and 0,8267% for Tablet A, and accuracy parameters with mean percent recovery of paracetamol and tramadol HCl of 99,71% and 100,23% for Tablet S and 99,90% and 100,11% for Tablet A, respectively. All the validation parameters are within the acceptable range. Based on the above description, it can be concluded that the determination of paracetamol and tramadol HCl levels using PLS multivariate chemometric and absorbance ratio method meets the requirements for tablet preparations according to Indonesian Pharmacopoeia VI Edition (2020).