Pengembangan Metode Spektrofotometri Inframerah (FTIR) secara Kemometrik terhadap Penentuan Kadar Simultan Campuran Isoniazid dan Vitamin B6 dalam Sediaan Tablet

Abstract

Background: Drug levels testing requires a quantitative analysis method that needs cheaper equipment and operational costs, is easier to implement, and can provide results with good accuracy and precision. Therefore, an infrared spectrophotometry (FTIR) method by chemometric partial least squares (PLS) for multivariate calibration needs to be develop. A mixture of isoniazid with vitamin B6 has been widely circulated and used by the public. Objective: This study aimed to determine the simultaneous levels of isoniazid and vitamin B6 mixtures in tablet preparations using infrared spectrophotometry (FTIR) method by chemometric (PLS) for multivariate calibration. Methods: The calibration model was made from each of the 5 concentrations of isoniazid (w/w) and vitamin B6 (w/w) which measured at wavenumber of 779,24-713,66 cm-1 and 829,39-763,81 cm-1. Then, chemometric validation was performed by evaluating the results of R2, PRESS, and RMSECV. Then, the determination of levels using a divisor factor was proceed at wavenumber of 779,24-713,66 cm-1. Results: The method used in this study has met the chemometric validation parameter requirements on the PLS for multivariate calibration of isoniazid and vitamin B6 as seen from the results with RMSECV values, respectively, of 0,3675 and 0,2283; PRESS values, respectively, of 0,8106 and 0,3129; and R2 values, respectively, of 0,9996 and 0,9969, which indicate the predictive capabilities were still acceptable and well-used for levels determination. The levels determination results of isoniazid content in INHA® 400 and Pehadoxin Forte® tablets was 102,90% and 105,45% and vitamin B6 content was 98,93% and 101,57%, respectively. Conclusion: Based on the results of this study, it can be concluded that the levels determination of isoniazid and vitamin B6 mixtures by an infrared spectrophotometry (FTIR) method using chemometric (PLS) for multivariate calibration can be use and has met the levels requirements for tablet preparations according to Indonesian Pharmacopoeia 6th Edition (2020).