Drug impurity profiling strategies

S. Görög, M. Babják, G. Balogh, J. Brlik, A. Csehi, F. Dravecz, M. Gazdag, P. Horváth, A. Laukó, K. Varga

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A general scheme is set up for the estimation of the impurity profile of bulk drug substances by the complex use of chromatographic, spectroscopic and hyphenated techniques. Several examples are presented as illustrations to the scheme from the authors laboratory involving the use of chromatographic methods such as thin-layer-(TLC), gas-(GC), analytical and preparative high-performance liquid chromatography (HPLC), spectroscopic methods such as mass spectrometry (MS) and NMR spectroscopy as well as hyphenated techniques (HPLC/diode-array UV, GC/MS and HPLC/MS). In addition to summarizing earlier work, new examples are also presented: identification of an impurity (propyl 4-[diethylcarbamoyl(methoxy)]-3-methoxy phenylglyoxylate, II) in propanidid (I) and two unsaturated impurities in allylestrenol (VII) by GC/MS and HPLC/diode-array UV as well as estimation of the impurity profile of mazipredone (III) by HPLC/MS and HPLC/diode-array UV.

Original languageEnglish
Pages (from-to)1517-1526
Number of pages10
Issue number9
Publication statusPublished - Sep 1997



  • Allylestrenol
  • Impurities
  • Mazipredone
  • Propanidid

ASJC Scopus subject areas

  • Analytical Chemistry

Cite this

Görög, S., Babják, M., Balogh, G., Brlik, J., Csehi, A., Dravecz, F., Gazdag, M., Horváth, P., Laukó, A., & Varga, K. (1997). Drug impurity profiling strategies. Talanta, 44(9), 1517-1526. https://doi.org/10.1016/S0039-9140(96)02179-0