SIMULTANEOUS ANALYSIS OF ISONIAZID AND PYRIDOXINE HYDROCHLORIDE IN TABLETDOSAGE FORM USING PARTIAL LEAST SQUARES BASED ON INFRAREDSPECTRA PROFILE

Objective: The purpose of this research was to simultaneously analyse a mixture of Isoniazid (INH) and Pyridoxine Hydrochloride (PDX) in tablet dosage form using Partial Least Square (PLS) based on infrared spectra profile. Methods: The calibration models were measured at five concentrations levels (w/w) of INH and PDX within the wavenumber ranges of 779.24-713.66 cm-1for INH and 829.39-763.81 cm-1for PDX. Model performance was evaluated through internal validation using leave-one-out-cross validation (LOO-CV), with accuracy and precision assessed by the coefficient of determination (R2), Prediction Error Sum of Squares (PRESS), and Root mean Square Error of Cross Validation (RMSECV). Divisor approach was applied to separate the spectrum of the individual components within the mixture. Results: The PLS models for INH and PDX levels showed excellent validation results, with R2 values of 0.9996 and 0.9969, PRESS values of 0.8106 and 0.3129, and RMSCEV values of 0.3675 and 0.2283, respectively. The INH level on INHA® 400 and Pehadoxin Forte® tablets were 102.90% and 105.45% of the labelled amount, while the PDX level was 98.93% and 101.57% of the labelled amount, respectively. Conclusion: The PLS model based on infrared spectra profiles demonstrated high accuracy, precision, and effectiveness, offering a non-destructive method for simultaneous analysis of INH and PDX in tablet dosage form. This method is applicable to pharmaceutical quality monitoring.