Methods of validating a test instrument

20-Mar-2020 04:07

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In general terms, then, the requirements and performance parameters must first be defined for every analytical method and purpose of analysis; and second, the value for these parameters must be estimated and checked to see if they really meet the criteria.This is an essential condition if the results provided are to be used.Repeatability is obtained when the analysis is carried out in a laboratory by an operator using a piece of equipment over a relatively short time span.Intermediate precision is determined by comparing the results of a method run within a single laboratory variations: different days, different analyst, different equipment, etc.The parameters, as defined by the ICH and by other organizations and authors, are described in brief in the following paragraphs.The term specificity usually refers to a method that produces a response for a single analyte only, while the term selectivity refers to a method that provides responses for a number of chemical entities that may or may not be distinguished from each other.Pharmaceutical QC precision of greater than 1percent RSD is easily achieved for compound analysis, but the precision for biological samples is more like 15 percent at the concentration limits and 10 percent at other concentration levels dependent on the sample matrix, the concentration of the analyte, the performance of the equipment and the analysis technique.It can vary between 2 percent and more than 20 percent.

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The USP defines the selectivity of an analytical method as its ability to determine an analyte accurately in the presence of interference, such as synthetic precursors, excipients, enantiomers and known (or likely) degradation products that may be expected to be present in the sample matrix.

One alternative is to compare the results of the method with results from an established reference method.

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