Quantifying low levels of polymorphic impurity in clopidogrel bisulphate by vibrational spectroscopy and chemometrics

Zoltán Német, Ádám Demeter, György Pokol

Research output: Article

18 Citations (Scopus)

Abstract

Vibrational spectroscopic methods were developed for quantitative analysis of Form II of clopidogrel bisulphate in Form I and Form II polymorphic mixtures. Results show that both IR and Raman spectroscopy combined with chemometrics are suitable to quantify low levels of Form II in Form I, down to 2 and 3%, respectively, with less than 1% limit of detection. Different preprocessing and multivariate methods were applied for spectral processing and were compared to find the best chemometric model. Common problems of quantitative vibrational spectroscopy in the solid phase are discussed; and procedures appropriate to eliminate them are proposed.

Original languageEnglish
Pages (from-to)32-41
Number of pages10
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume49
Issue number1
DOIs
Publication statusPublished - jan. 15 2009

ASJC Scopus subject areas

  • Analytical Chemistry
  • Pharmaceutical Science
  • Drug Discovery
  • Spectroscopy
  • Clinical Biochemistry

Fingerprint Dive into the research topics of 'Quantifying low levels of polymorphic impurity in clopidogrel bisulphate by vibrational spectroscopy and chemometrics'. Together they form a unique fingerprint.

  • Cite this