Abstract
REVIEW ARTICLE: SYSTEM SUITABILITY PARAMETERS AND SPECIFICATIONS

Prof. Anand D. Savkare* and Jayshri D. Kauthale

ABSTRACT

System suitability test (SST) is a test to determine the suitability and effectiveness of chromatographic system prior to use. The performance of any chromatographic system may continuously change during their regular use, which can affect the reliability of the analytical results. For this reason different parameters which are related to the operation of the whole chromatographic system can be monitored and investigated to find out the integrity and reliability of the whole HPLC system. The parameters that can be used to determine system suitability prior to analysis includes the number of effective theoretical plates, resolution, asymmetry/tailing factor, selectivity ,capacity factor ,relative retention and relative standard deviation(RSD). After checking the parameters, the system is then only can be declared suitable if the responses are within permitted limits. This study was performed to set system suitability criteria for development and validation of the HPLC analysis. In very simpler way, we also discuss about the measurement and calculations of different SST parameters.

Keywords: HPLC, System suitability test, ICH, USP.


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