Optimized and validated HPLC methods for compendial quality assessment I. Methylxanthine derivatives

Zs Budvári-Bárány, G. Szász, K. Gyimesi-Forrás

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

The HPLC method suggested here is suitable for the detection and quantitative determination of 0.1-1% caffeine, theobromine and theophylline impurities in each of these methylxanthine derivatives. The system optimization includes organic modifier content. ionic strength, eluent flow rate and concludes to the use of a simple C18/methanol-water 1:4 (I = 0.1) chromatographic system. The limit of impurity detection was found to be 15 ng (theobromine, theophylline) and 30 ng (caffeine). The range of quantitation extends from 31.25 to 250 ng. The accuracy (percentage of recovery) and precision (repeatability) of the method are tabulated. The method, considering validation requirements of USP XXIII, demonstrates the suitability of HPLC for selective compendial purity tests.

Original languageEnglish
Pages (from-to)1233-1242
Number of pages10
JournalJournal of Liquid Chromatography and Related Technologies
Volume20
Issue number8
Publication statusPublished - 1997

Fingerprint

Theobromine
Theophylline
Caffeine
High Pressure Liquid Chromatography
Impurities
Derivatives
Ionic strength
Methanol
Flow rate
Recovery
Osmolar Concentration
Limit of Detection
Water
methylxanthine

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Analytical Chemistry

Cite this

Optimized and validated HPLC methods for compendial quality assessment I. Methylxanthine derivatives. / Budvári-Bárány, Zs; Szász, G.; Gyimesi-Forrás, K.

In: Journal of Liquid Chromatography and Related Technologies, Vol. 20, No. 8, 1997, p. 1233-1242.

Research output: Contribution to journalArticle

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