Abstract
Introduction: This study aimed at developing a technology to measure the hardness of Ibuprofen (IBU) tablets and optimize the IBU formulation using Near-infrared (NIR) spectroscopy.
Materials and Methods: Tablets (400 mg±5%, 10mm in diameter) consisting of IBU, microcrystalline cellulose SH-103, carboxymethyl starch sodium, magnesium stearate, silicon dioxide were formed of various hardness (2kg, 4kg, 6kg, 8kg, 10kg, 12kg). The reflectance NIR spectra of various tablets were employed to establish 9 calibrations models, which were further used to predict tablet hardness by Partial least squares (PLS) and principal component regression (PCR) analysis.
Results and Conclusion: Cross-validation with independent samples shows that PLS is the optimal predictive model. Which R2=0.9832, RSECV=0.334 and RSE=0.0669. This study established a new, simple, rapid, nondestructive and reliable methodology to optimize the IBU tablet hardness.
Keywords: Near-infrared diffuse reflectance spectroscopy, IBU tablet, hardness, PLS, PCR, pharmaceutical.
Graphical Abstract
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