Development and validation of a method for the analysis of a pharmaceutical preparation by near-infrared diffuse reflectance spectroscopy

Journal of Pharmaceutical Sciences

Volumn 88, Issue 5, 1999, Pages 551-556

  Blanco, Marcelo ^a   Coello, Jordi ^a   Eustaquio, Alba ^a   Iturriaga, Hortensia ^a   Maspoch, Santiago ^a  

^a UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; EXCIPIENT; FERROUS LACTATE DIHYDRATE; LACTIC ACID DERIVATIVE; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; DRUG DISCRIMINATION; DRUG IDENTIFICATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; DRUG SCREENING; INFRARED SPECTROSCOPY; SPECTRAL SENSITIVITY;

EID: 0032897779     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1021/js980338f     Document Type: Article

References (22)

1. Corti, P.; Dreassi, E.; Lonardi, S. Near Infrared Reflectance Analysis: Features and Applications in Pharmaceutical and Biomedical Analysis. Il farmaco 1993, 48 (1), 3-20.
2. Blanco, M.; Coello, J.; Iturriaga, H.; Maspoch, S.; de la Pezuela, C. Near-infrared spectroscopy in the pharmaceutical industry. Analyst 1998, 123, 135R-150R.
3. Khan, P. R.; Jee, R. D.; Watt, R. A.; Moffat, A. C. The identification of Active Drugs in Tablets using Near Infrared Spectroscopy. J. Pharm. Sci. 1997, 3, 447-453.
4. Blanco, M.; Coello, J.; Iturriaga, H.; Maspoch, S.; de la Pezuela, C.; Russo, E. Control Analysis of a Pharmaceutical Preparation by Near-infrared Reflectance Spectroscopy. A Comparative Study of a Spinning Module and Fibre Optic Probe. Anal. Chim. Acta 1994, 298, 183-191.
5. Blanco, M.; Coello, J.; Iturriaga, H.; Maspoch, S.; de la Pezuela, C. Strategies for Constructing the Calibration Set in the Determination of Active Principles in Pharmaceuticals by Near Infrared Diffuse Reflectance Spectrometry. Analyst 1997, 112, 761-765.
6. Blanco, M.; Coello, J.; Iturriaga, H.; Maspoch, S.; de la Pezuela, C. Quantitation of the Active Compound and Major Excipients in a Pharmaceutical Formulation by Near Infrared Diffuse Reflectance Spectroscopy with Fibre Optical Probe. Anal. Chim. Acta 1996, 333, 147-156.
7. Wu, W.; Walczak, B.; Massart, D. L.; Prebble, K. A.; Last, I. R. Spectral Transformation and Wavelength Selection in Near-infrared Spectra Classification. Anal. Chim. Acta 1995, 315, 243-255.
8. Shah, N. K.; Gemperline, P. J. Combination of the Mahalanobis Distance and Residual Variance Pattern Recognition Techniques for Classification of Near-infrared Reflectance Spectra. Anal. Chem. 1990, 62, 465-470.
9. Martens, H.; Naes, T. Multivariate Calibration; Wiley: New York, 1991.
10. Green, J. M. A Practical Guide to Analytical Method Validation. Anal. Chem. News Features 1996, 68, 305A-309A.
11. Huber, L. Validation of Analytical Methods: Review and Strategy. LC-GC Int. 1998, 11 (2), 96-105.
12. U. S. Pharmacopeia 23; United States Pharmacopeial Convention, Inc., 1994; pp 1982-1984.
13. Harmonised Tripartite Guideline: Validation of Analytical Procedures Methodology, International Conference on Harmonisation (ICH), The European Agency for the Evaluation of Medicinal Products, London, 1996.
14. Reviewer Guidance, Validation of Chromatographic Methods; Center of Drug Evaluation and Research, Food and Drug Administration: Washington, D.C., 1994.
15. Vogel, A. I. A text-book of quantitative inorganic analysis including elementary instrumental analysis; Longman group limited: London, 1961; p 322.
16. Koltoff, I. M.; Sandell, E. B.; Meehan, E. J.; Bruckenstein, S. Quantitative Chemical analysis; The Macmillan Company: London, 1969; p 838.
17. Geladi, P.; Kowalski, B. Partial Least-squares Regression: a Tutorial. Anal. Chim. Acta 1986, 185, 1-17.
18. Haaland, D. M.; Thomas, E. V. Partial Least-squares Methods for Spectral Analyses. Relation to other Quantitative Calibration Methods and the Extraction of Qualitative Information. Anal. Chem. 1988, 60, 1193-1202.
19. Otto, M.; Wegscheider, W. Spectrophotometric Multicomponent Analysis Applied to Trace Metal Determinations. Anal. Chem. 1985, 57, 63-69.
20. Riley, M. R.; Arnold M. A.; Murhammer D. W. Matrix-Enhanced Calibration Procedure for Multivariate Calibration Models with Near-Infrared Spectra. Appl. Spectrosc. 1998, 52 (10), 1339-1347.
21. Miller, J. C.; Miller J. N. Statistics for analytical chemistry; Chalmers R. A., Masson M., Eds., Ellis Horwood Series in Analytical Chemistry: Chichester, 1984; p 56.
22. Miller, J. C.; Miller J. N. Statistics for analytical chemistry, Chalmers R. A., Masson M., Eds., Ellis Horwood Series in Analytical Chemistry: Chichester, 1984; p 102.