A novel method for analyzing thick tablets by near infrared spectroscopy
AUTOR(ES)
Ramirez, José L.
FONTE
Springer-Verlag
RESUMO
A near-infrared (NIR) spectroscopic method to determine content uniformily of a large, thick tablet using an approach that could facilitate future validations has been developed. A CT ibuprofen 800-mg tablet weighs about 1150 mg and is about 18.6 mm wide and 7.6 mm thick. The FT NIR spectrometer was optimized for transmission spectra of the tablets by moving it to the sample compartment and placing it immediately behind the tablet. In spite of this dedicated setup, the transmission spectra obtained were very poor, indicating that the NIR radiation was not reaching the detector. The spectra of the tablet improved with use of a simple preparation in which a flat-face die applies pressure of 20 000 psi to the tablet, this reduced the thickness of the tablet from 7.6 mm to 3.6 mm. A calibration model was developed for tablets with drug content ranging from 70% to 130% of label. The calibration model was tested using a validation set of tablets with a drug content of 752, 800, and 848 mg. The results obtained were within 1.5% of the known drug content of the validation set, tablets. Even with the sample preparation, the content uniformity results of 10 tablets could be determined using this method in less than 1 hour. The approach described in this article could also be used to validate NIR content uniformity methods for orther formulations.
ACESSO AO ARTIGO
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2750576Documentos Relacionados
- A quantitative method using near infrared imaging spectroscopy for determination of surface composition of tablet dosage forms: an example of spirolactone tablets
- Classification of tablets containing dipyrone, caffeine and orphenadrine by near infrared spectroscopy and chemometric tools
- Comparative determination of polymorphs of indomethacin in powders and tablets by chemometrical near-infrared spectroscopy and X-ray powder diffractometry
- Extracerebral absorption of near infrared light influences the detection of increased cerebral oxygenation monitored by near infrared spectroscopy.
- A Novel Thermal Infrared Enthalpimetric Method for Fast, High-Throughput Determination of the Content Uniformity of Captopril Tablets