title: Nondestructive tablet hardness testing by near-infrared spectroscopy: a new and robust spectral best-fit algorithm.
abstract: A new algorithm using common statistics was proposed for nondestructive near-infrared (near-IR) spectroscopic tablet hardness testing over a range of tablet potencies. The spectral features that allow near-IR tablet hardness testing were evaluated. Cimetidine tablets of 1-20% potency and 1-7 kp hardness were used for the development and testing of a new spectral best-fit algorithm for tablet hardness prediction. Actual tablet hardness values determined via a destructive diametral crushing test were used for construction of calibration models using principal component analysis/principal component regression (PCA/PCR) or the new algorithm. Both methods allowed the prediction of tablet hardness over the range of potencies studied. The spectral best-fit method compared favorably to the multivariate PCA/PCR method, but was easier to develop. The new approach offers advantages over wavelength-based regression models because the calculation of a spectral slope averages out the influence of individual spectral absorbance bands. The ability to generalize the hardness calibration over a range of potencies confirms the robust nature of the method.
authors.affiliation: Merck&Company, Incorporated, West Point, PA 19486, USA.
authors.forename: J D
authors.initials: JD
authors.lastname: Kirsch
authors.forename: J K
authors.initials: JK
authors.lastname: Drennen
mesh_terms: D000465:Algorithms; D002626:Chemistry, Pharmaceutical; D002927:Cimetidine / Q000032:analysis*; D006245:Hardness Tests / Q000379:methods*; D008962:Models, Theoretical; D015999:Multivariate Analysis; D011237:Predictive Value of Tests; D011312:Pressure; D012044:Regression Analysis; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013607:Tablets
chemical_list: D013607:Tablets; D002927:Cimetidine