Comparative determination of polymorphs of indomethacin in powders and tablets by chemometrical near-infrared spectroscopy and x-ray powder diffractometry

AAPS PharmSciTech

Volumn 4, Issue 2, 2003, Pages

  Otsuka, Makoto ^a   Kato, Fumie ^a   Matsuda, Yoshihisa ^a   Ozaki, Yukihiro ^b  

^a KOBE PHARMACEUTICAL UNIVERSITY   (Japan)

^b KWANSEI GAKUIN UNIVERSITY   (Japan)

Author keywords

Chemometrics; Indomethacin; Near infrared spectroscopy; Polymorph; X ray powder diffractometry

Indexed keywords

HYDROXYPROPYLCELLULOSE; INDOMETACIN; LACTOSE; STARCH; NONSTEROID ANTIINFLAMMATORY AGENT;

ACCURACY; ARTICLE; CHEMOMETRIC ANALYSIS; CONTROLLED STUDY; CORRELATION COEFFICIENT; DRUG FORMULATION; INTERMETHOD COMPARISON; NEAR INFRARED SPECTROSCOPY; PREDICTION; QUANTITATIVE ANALYSIS; REGRESSION ANALYSIS; REPRODUCIBILITY; TABLET FORMULATION; X RAY DIFFRACTION; CHEMISTRY; COMPARATIVE STUDY; POWDER; TABLET;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CHEMISTRY, PHARMACEUTICAL; INDOMETHACIN; POWDERS; SPECTROSCOPY, NEAR-INFRARED; TABLETS; X-RAY DIFFRACTION;

EID: 23144464169     PISSN: 15309932     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/pt040219     Document Type: Article

References (23)

1. FDA Papers. Guidelines: manufacturing and controls for INDs and NDAs. Pharm Tech Japan. 1985;1:835-850.
2. Haleblian JK. Characterization of habits and crystalline modification of solids and their pharmaceutical applications. J Pharm Sci. 1975;64:1269-1288.
3. Otsuka M, Matsuda Y. Polymorphism, pharmaceutical aspects. In: Swarbrick J, Boylan JC, eds. Encyclopedia of Pharmaceutical Technology. Vol 12. New York, NY: Marcel Dekker; 1995:305-326.
4. Yoshino H, Hagiwara Y, Kobayashi S, Samejima M. Estimation of polymorphic transformation degree of pharmaceutical raw materials. Chem Pharm Bull. 1984;32:1523-1536.
5. Kaneniwa N, Otsuka M, Hayashi T. Physicochemical characterization of indomethacin polymorphs and the transformation kinetics in ethanol. Chem Pharm Bull. 1985;33:3447-3455.
6. Ahmed H, Buckton G, Rawlins DA. The use of isothermal microcalorimetry in the study of small degree of amorphous content of a hydrophobic powder. Int J Pharm. 1996;130:195-201.
7. Black DB, Lovering EG. Estimation of the degree of crystallinity in digoxin by X-ray and infrared methods. J Pharm Pharmacol. 1977;29:684-687.
8. Taylor LS, Zografi G. The quantitative analysis of crystallinity using FT-raman spectroscopy. Pharm Res. 1998;15:755-761.
9. Berridge JC, Jones P, Roberts-McIntosh AS. Chemometrics in pharmaceutical analysis. J Pharm Biomed Anal. 1991;9:597-604.
10. Edlund U, Grahn H. Multivariate data analysis of NMR data. J Pharm Biomed. Anal. 1991;9:655-658.
11. Lincoln D, Fell AF, Anderson NH, England D. Assessment of chromatographic peak purity of drugs by multivariate analysis of diode-array and mass spectrometric data. J Pharm Biomed Anal. 1992;10:837-844.
12. Otsuka M, Kato F, Matsuda Y. Comparative evaluation of the degree of indomethacin crystallinity by chemoinfometrical Fourier-transformed near-infrared spectroscopy and conventional powder X-ray diffractometry. PharmSci. 2000;2, Article 9.
13. Morisseau KM, Rhodes CT. Near-infrared spectroscopy as a nondestructive alternative to conventional tablet hardness testing. Pharm Res. 1997;14:108-111.
14. Drennen JK, Lodder RA. Nondestructive near-infrared analysis of intact tablets for determination of degradation products. J Pharm Sci. 1990;79:622-627.
15. Buchanan BR, Baxter MA, Chen TS, Qin XZ, Robinson PA. Use of near-infrared spectroscopy to evaluate an active in a film-coated tablet. Pharm Res. 1996;13:616-621.
16. Frake P, Gill I, Luscombe CN, Rudd DR, Waterhouse J, Jayasooriya UA. Near-infrared mass median particle size determination of lactose monohydrate, evaluating several chemometric approaches. Analyst. 1998;123:2043-2046.
17. Martents H, Næs T. Multivariate Calibration. New York, NY: John Wiley & Sons; 1989.
18. Norris T, Aldridge PK, Sekulic SS. Determination of endpoints for polymorph conversions of crystalline organic compounds using on-line near-infrared spectroscopy. Analyst. 1997;122:549-552.
19. Saver RW, Meulman PA, Bowerman DK, Havens JL. Factor analysis of infrared spectra for solid-state forms of delavirdine mesylate. Int J Pharm. 1998;167:105-120.
20. Patel AD, Luner PE, Kemper MS. Low-level determination of polymorph composition in physical mixtures by near-infrared reflectance spectroscopy. J Pharm Sci. 2001;90:360-370.
21. Otsuka M, Kato F, Matsuda Y. Determination of indomethacin polymorphic contents by chemometric near-infrared spectroscopy and conventional powder X-ray diffractometry. Analyst. 2001;126:1578-1582.
22. Blanco M, Villar A. Polymorphic analysis of a pharmaceutical preparation by NIR spectroscopy. Analyst. 2000;125:2311-2314.
23. Patel AD, Luner PE, Kemper MS. Quantitative analysis of polymorphs in binary and multi-component powder mixtures by near-infrared reflectance spectroscopy. Int J Pharm. 2000;206:63-74.