Near infrared spectroscopy combination with PLS to monitor the parameters of naproxen tablet preparation process

摘要

Near infrared spectroscopy (NIRs) in combination with chemometrical techniques partial least squares is an effective, expeditious and nondestructive technique to analyse various parameters of interest to the pharmaceutical industry. In this work, we explored the use of NIR spectroscopy for the determination of physical (compression force, tablet hardness, mean particle size and particle size distribution) and chemical parameters (content uniformity). To measure tablet content uniformity, naproxen tablets with drug content ranging from 80% to 120% were made and analyzed using high performance liquid chromatography (HPLC) and NIR spectroscopy. For models of the compression force and hardness, the tablets were made by Rotary tablet press and the compression force was varied from 5.7 to 46.0 kN. The samples of mean particle size and particle size distribution were passed through sieves of different sieve opening to obtain six size fractions. The correlation coefficient (R), root mean square error of calibration (RMSEC), root mean square error of prediction (RMSEP) and root mean square error of cross-validation (RMSECV) have been used to assess the predictive ability and robustness of the different partial least squares (PLS) models.