Quantitative determination of crystallinity of alpha-lactose monohydrate by Near Infrared Spectroscopy (NIRS)

Ágota Gombás, I. Antal, P. Szabó-Révész, Sylvia Marton, I. Erös

Research output: Contribution to journalArticle

64 Citations (Scopus)

Abstract

The purpose of this study was to determine quantitatively the crystallinity in crystalline/amorphous powder mixtures of lactose, to asses the capability of Near Infrared Spectroscopy (NIRS) for quantitative determination of crystallinity and to compare the accuracy of the NIRS method with that of conventional X-ray powder diffraction (XRPD). Amorphous lactose was prepared by spray drying. Samples with different crystallinity were prepared by physical mixing of 100% amorphous and 100% crystalline materials. The samples were characterized by XRPD and NIRS. Analysis was performed on the data sets by multiple linear regression (MLR). There is a close correlation between the predicted and the actual crystallinity of physical mixtures of crystalline and amorphous lactose, determined by NIRS (R2=0.9994). NIRS results were compared to the XRPD using the same sample sets. The correlation coefficients was 0.9981. The results showed that NIRS is an useful method for accurately determining low quantities of the crystalline lactose in a physical mixture. Therefore, NIRS can be used for the quantitative determination of crystallinity of materials during pharmaceutical procedures.

Original languageEnglish
Pages (from-to)25-32
Number of pages8
JournalInternational Journal of Pharmaceutics
Volume256
Issue number1-2
DOIs
Publication statusPublished - Apr 30 2003

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Near-Infrared Spectroscopy
Lactose
Powder Diffraction
X-Ray Diffraction
Equidae
Powders
Linear Models
Pharmaceutical Preparations

Keywords

  • Amorphous
  • Crystalline
  • Lactose
  • Near Infrared Spectroscopy
  • X-ray powder diffraction

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

Quantitative determination of crystallinity of alpha-lactose monohydrate by Near Infrared Spectroscopy (NIRS). / Gombás, Ágota; Antal, I.; Szabó-Révész, P.; Marton, Sylvia; Erös, I.

In: International Journal of Pharmaceutics, Vol. 256, No. 1-2, 30.04.2003, p. 25-32.

Research output: Contribution to journalArticle

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