The paradigm shifting role of chromatographic methods in pharmaceutical analysis

Journal of Pharmaceutical and Biomedical Analysis
Sándor Görög

Abstract

An overview is presented of the impact of chromatographic method developments on the quality control of pharmaceuticals as of the 1950s up until the present times. This survey is mainly based on the changes in pharmacopeias starting with United States Pharmacopeia (USP) 16, issued in 1960, up to the presently effective USP 34 and European Pharmacopeia 7.2. At the beginning of this period the role of chromatographic methods was negligible and was restricted to classical column chromatography and paper chromatography. However, the invention of high-performance liquid chromatography (HPLC) initiated a rapid paradigm shift in the attitude toward, and the use of, chromatographic methods. As a result, HPLC began a "career" of rapid spreading and development, and by now has undoubtedly become the principal method in pharmaceutical analysis. Likewise, the role of thin-layer chromatography (TLC) and to a lesser extent gas chromatography is also remarkable. The role of these and electrophoretic methods in the identification, assay and purity check of drugs and drug products in the modern pharmacopeias is discussed. As a case study the stability investigation of Depersolone® injection carried out in the 1960s and 35 years later is present...Continue Reading

References

Jan 12, 1999·Journal of Pharmaceutical and Biomedical Analysis·M GazdagS Görög
Oct 14, 2005·Bioscience Reports·Reiner Westermeier, Rita Marouga
Jun 2, 2007·Journal of Pharmaceutical and Biomedical Analysis·Jeffrey D HoferEugene C Rickard
Dec 18, 2007·Journal of Pharmaceutical and Biomedical Analysis·Sándor Görög
Mar 28, 2008·Journal of Chromatographic Science·Leslie S Ettre
Jul 15, 2009·Journal of Pharmaceutical and Biomedical Analysis·Peter J SkrdlaJean Wyvratt
Feb 4, 2010·Journal of Chromatography. a·Fabrice Gritti, Georges Guiochon
Mar 2, 2010·Electrophoresis·Richie RyanKevin Altria
Jan 25, 2011·Journal of Chromatography. a·K Ferenczi-FodorB Renger
Mar 1, 2011·Journal of Chromatography. a·Georges Guiochon, Fabrice Gritti

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Citations

Jun 1, 2013·Journal of Pharmaceutical and Biomedical Analysis·Dhavalkumar Narendrabhai PatelHwee-Ling Koh
May 27, 2016·Journal of Chromatographic Science·Premjeet Singh SandhuBhupinder Singh

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