Plate Number Requirements for Establishing Method Suitability

Abstract

Establishing the suitability of an analytical system has become a routine requirement in the testing of modern pharmaceuticals. Acceptable parameters that illustrate the system is performing as intended and in an equivalent manner to the original validation are often set at the time of method validation and transferred with the method to the production laboratory. For chromatographic methods, these parameters include--but are not limited to--resolution, tailing, and plate number specifications. Transferring methods is often a seamless transition from research to quality control. However, far too often the quality group receives arguably "overzealous" and strict requirements for the method. More specifically, chromatographic methods get issued with plate number specifications that far exceed the minimum number required to achieve sufficient resolution of the analytes. Presented here is a discussion of the setting of realistic plate number specifications that still maintain the minimum resolution of the chromatographic critical pair.

Reliable Methods for Analyses of Volatile Compounds of Copaifera Oleoresins Combining Headspace and Gas Chromatography

“…(2011) . Chromatographic resolution for all analytes was in accordance with the literature data . Relative standard deviation for chromatographic investigated parameters was within the set limits.…”

System suitability in bioanalytical LC/MS/MS

“…For instance, the USP [9,10] describes potential testing parameters for system suitability in chromatography [10] and capillary electrophoresis [9] but does not give a defined procedure for implementation in a laboratory. Other sources provide general approaches to determine system suitability in chemical analysis [12,13]; however, only recently has a procedure for system suitability testing in bioanalysis been presented [14]. The remainder of this report will focus on an approach for system suitability testing that can be used for bioanalysis based on LC/MS/MS.…”