View More View Less
  • 1 Department of Analytical Chemistry, Medical University of Gdansk, Gen. J. Hallera 107 Str., 80-416, Gdansk, Poland
Restricted access

Abstract

The purpose of this study was to learn, to what extent the DSC, FT-IR and Raman spectroscopy can be useful for evaluation of the quality of medicinal products, the composition of marketed pharmaceutical preparations. As many as twenty-seven commonly available medicinal products were chosen, of which the majority constitute the so-called over-the-counter drugs. As basic active pharmaceutical ingredients (APIs), the products contained methylxanthines: theophylline, diprophylline and caffeine. The study has shown that in many cases the three techniques can be useful for the detection of APIs in medicinal products. To reach this aim, well-shaped endothermic DSC peaks, appearing due to melting of the active constituents and the so-called matching factors of the FT-IR and Raman spectra related to those of API used as standards, were utilised. The results obtained by Raman spectroscopy were satisfying to a limited extent only. On the other hand, the matching factors were twice less effective than the results obtained by the FT-IR technique. In the case of the preparations with caffeine, the matching factors were several times less effective than those obtained by FT-IR. An exception to this rule are only medicinal products containing acetylsalicylic acid, whose matching factors were several times higher than those of FT-IR, but because of their low concentrations, it was impossible to detect the ingredient in the sample.

  • 1. European Pharmacopoeia 5. Strasbourg: Council of Europe; 2005.

  • 2. Polish Pharmacopoeia VIII. Warsaw: Ministry of Health; 2008.

  • 3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH. http://www.ich.org/home.htlm. Accessed 16 Sep 2011.

    • Search Google Scholar
    • Export Citation
  • 4. Macedo, RO, Do Nascimento, TG 2002 Quality control of thiabendazole pre-formulation and tablets by TG and DSC coupled to the photovisual system. Thermochim Acta 392–393:8592 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 5. Gomes APB , Correia LP, da Silva Simoes MO, Macedo RO. Development of thermogravimetric method for quantitative determination of ketoconazole. J Therm Anal Calorim. 2008;91: 31721.

    • Search Google Scholar
    • Export Citation
  • 6. Lappalainen, M, Karppinen, M 2010 Techniques of differential scanning calorimetry for quantification of low contents of amorphous phases. J Therm Anal Calorim 102:171180 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 7. S Sasic Y Ozaki eds. 2010 Raman, infrared and near-infrared chemical imaging Wiley Hoboken.

  • 8. Vergote, GJ, Vervaet, Ch, Remon, JP, Haemers, T, Verpoort, F 2002 Near-infrared FT-Raman spectroscopy as a rapid analytical tool for the determination of diltiazem hydrochloride in tablets. Eur J Pharm Sci 16:6367 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 9. Roggo, Y, Degardin, K, Margot, P 2010 Identification of pharmaceutical tablets by Raman spectroscopy and chemometrics. Talanta 81:988995 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 10. Tanase, C, Odochian, L, Apostolescu, N, Pui, A 2011 TG-FTIR analysis applied to the study of thermal behaviour of some edible mushrooms. J Therm Anal Calorim 103:10791085 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 11. Polish Pharmacopoeia VI. Vol. 1. Warsaw: Ministry of Health; 2002.

  • 12. Polish Pharmacopoeia VII. Vol. 1. Warsaw: Ministry of Health; 2006.

  • 13. Vajna, B, Farkas, I, Szabo, A, Zsigmond, Z, Marosi, G 2010 Raman microscopic evaluation of technology dependent structural differences in tablet containing imipramine model drug. J Pharm Biomed Anal 51:3038 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 14. Hausman, DS, Cambron, RTh, Sakr, A 2005 Application of on-line Raman spectroscopy for characterizing relationships between drug hydration state and tablet physical stability. Int J Pharm 299:1933 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 15. Tkachenko, ML, Zhnyakina, LE, Kosmynin, AS 2003 Physicochemical investigation of paracetamol—caffeine solid mixtures. Pharm Chem J 37:430432 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 16. Bi, M, Hwang, S-J, Morris, KR 2003 Mechanism of eutectic formation upon compaction and its effects on tablet properties. Thermochim Acta 404:213226 .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 17. Szczepaniak, W 2008 Instrumental methods in chemical analysis 5 WNT Warsaw (in Polish).

  • 18. Silverstein, RM, Webster, FX, Kiemle, DJ 2007 Spectroscopic methods for identification of organic compounds 2 PWN Warsaw (in Polish).

Manuscript Submission: HERE

  • Impact Factor (2019): 2.731
  • Scimago Journal Rank (2019): 0.415
  • SJR Hirsch-Index (2019): 87
  • SJR Quartile Score (2019): Q3 Condensed Matter Physics
  • SJR Quartile Score (2019): Q3 Physical and Theoretical Chemistry
  • Impact Factor (2018): 2.471
  • Scimago Journal Rank (2018): 0.634
  • SJR Hirsch-Index (2018): 78
  • SJR Quartile Score (2018): Q2 Condensed Matter Physics
  • SJR Quartile Score (2018): Q2 Physical and Theoretical Chemistry

For subscription options, please visit the website of Springer.

Journal of Thermal Analysis and Calorimetry
Language English
Size A4
Year of
Foundation
1969
Volumes
per Year
4
Issues
per Year
24
Founder Akadémiai Kiadó
Founder's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher
Chief Executive Officer, Akadémiai Kiadó
ISSN 1388-6150 (Print)
ISSN 1588-2926 (Online)

Monthly Content Usage

Abstract Views Full Text Views PDF Downloads
Jun 2021 0 0 0
Jul 2021 1 0 0
Aug 2021 1 0 1
Sep 2021 2 0 0
Oct 2021 4 0 0
Nov 2021 7 0 0
Dec 2021 1 0 0