title: Preliminary study of an offline simultaneous determination of metoprolol tartrate and hydrochlorothiazide in powders and tablets by reflectance near-infrared spectroscopy.
abstract: A preliminary study of the feasibility of using near-infrared spectroscopy (NIRS) for the offline simultaneous determination of metoprolol tartrate (MTP) and hydrochlorothiazide (HTZ) in powders and tablets has been carried out. An industrial tableting process was simulated using an instrumented tablet press replicator - Presster™. Conventional reference analytics were replaced with gravimetric analysis. The NIRS models for powder and tablet analysis were developed using 55 samples, and tested on 80 independent samples. Powder mixture components were weighed in glass vials to collect reference values, mixed and manually transferred to a tablet press replicator and compacted to form tablets. NIRS calibration models were developed using spectral and gravimetric reference data. The two model drugs were simultaneously quantified exhibiting root mean-squared error of prediction (RMSEP) of 1.69 and 1.31 mg for HTZ powder and tablet samples, respectively, and RMSEP of 3.15 and 3.00 mg for MTP powder and tablet samples, respectively. NIRS analysis of MTP and HTZ in powder and tablet form has not been reported elsewhere.
authors.affiliation: Department of Pharmaceutical Sciences, University of Basel , Basel , Switzerland .
authors.forename: Branko Z
authors.initials: BZ
authors.lastname: Vranic
authors.forename: Thierry F
authors.initials: TF
authors.lastname: Vandamme
mesh_terms: D002138:Calibration; D006852:Hydrochlorothiazide / Q000032:analysis*; D008790:Metoprolol / Q000032:analysis*; D011208:Powders; D012015:Reference Standards; D019265:Spectroscopy, Near-Infrared; D013607:Tablets
chemical_list: D011208:Powders; D013607:Tablets; D006852:Hydrochlorothiazide; D008790:Metoprolol
keywords: Diffuse reflectance; hydrochlorothiazide; metoprolol tartrate; simulation; tablet press replicator