title: Validation of thin layer and high performance thin layer chromatographic methods.
abstract: Analytical validation is a key requirement to asses and to prove a method's reliability and suitability for an intended use. Planar chromatographic procedures are used in different applications ranging from simple screening tests to sophisticated instrumental quantitative assays of analytes in complex matrices. This paper intends to give guidance on how to adopt international accepted formal requirements and guidelines for validation of these different TLC/HPTLC procedures. In addition, some selected parameters for robustness testing and for on going quality assurance of analytical performance based on control charts are reported.
authors.affiliation: Bernd Renger Consulting, Fritz-Reichle-Ring 2, 78315 Radolfzell, Germany. bernd.renger@br-consult.eu
authors.forename: B
authors.initials: B
authors.lastname: Renger
authors.forename: Z
authors.initials: Z
authors.lastname: Végh
authors.forename: K
authors.initials: K
authors.lastname: Ferenczi-Fodor
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods* / Q000592:standards*; D002855:Chromatography, Thin Layer / Q000295:instrumentation / Q000379:methods* / Q000592:standards*; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization