CONTRIBUTION TO CINCHONA ALKALOIDS CHEMISTRY

Ph.D. Thesis Abstract Contribution to cinchona alkaloids chemistry
2.4.2. Validation of the analysis method of QCI-ASA
.
To assess the quality of an analytical method, determined by its analytical performance, it
is needed a validation by analysis of reference substances with this method, followed by
comparing the results obtained on the basis of percentage retrievals and calculated relative
standard deviation (RSD%) [182].
Validation methodology is designed to demonstrate that an analytical method meets the
purpose for which it was developed and that the performance of such a method established by
experimental laboratory studies, meet the requirements for its application in determining the
analyte considered [183,184].
The validation process needs to specify the method validation parameters that must be
followed during this process.
method
Table 2.16. Performance parameters studied during the full validation of the analysis
parameters parameter description
linearity proportionality of the calibration model
Exactitatea Demonstration of the absence of systematic errors accuracy or consistency
Precision
- Repetability
- Reproductibility
In the
laboratory
of results with the true value or the arithmetic mean of results
Ability of the determination of the analyte, with resuts colse to 99-100%
Demonstration of the absence of random within-laboratory errors, or
their low value, the results demonstrated a correlation between them
- Featuring obtaining accurate results, repeated by the same analyst,
shortly
- Featuring obtain accurate results, repeated by the same analyst on
different days
Robustness Ability to remain unaffected method to small variations in method
parameters
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