The transfer of a LC-UV method for the determination of fenofibrate and fenofibric acid in Lidoses: Use of total error as decision criterion

The technique of thermal desorption (TD)-GC/MS was evaluated for the measurement of monoterpenes in indoor air. The validation strategy was intentionally oriented towards routine use and the reliability of the method rather than extreme performance. For this reason, validation by accuracy profile was chosen. The accuracy profile procedure, which is based on the concept of total error (bias + standard deviation), guarantees that a known proportion of future results obtained with the method will be within acceptance limits. For all the compounds tested in the present study, α-pinene, α-terpineol, β-pinene, d-limonene, ∆ 3 -carene, camphene, 1,8-cineole, p-cymene, linalool, but not in the case of carvone, the accuracy profile procedure established that at least 95% of the future results obtained would be within the ±15% acceptance limits of the validated method over the whole defined concentration range. Other parameters, such as selectivity, recovery, repeatability, stability of the molecules of interest and the effect of temperature, were also determined. The performance of the described method was finally evaluated by the analysis of indoor air from new timber frame constructions.

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“…This validation procedure, well described in the literature [28,29,[41][42][43][44][45][46][47][48][49], can be summarized as follows:…”

Section: Statistical Processing: Accuracy Profilementioning

confidence: 99%

“…With the results calculated from this study, a decrease in risk led to an increase in the LLOQ and, consequently, to a decrease in the validated range of concentrations. Furthermore, papers dealing with the accuracy profile procedure have obtained a probability of 95% [41][42][43][44][45][46][47][48][49]. Fig.…”

Section: Accuracy Profilementioning

confidence: 99%

Development and validation by accuracy profile of a method for the analysis of monoterpenes in indoor air by active sampling and thermal desorption-gas chromatography-mass spectrometry

Marlet

Lognay

2010

Talanta

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“…The probability that one of these cases arises when deciding about the acceptability of a method transfer depends on the statistical test used [8,[18][19][20]. The consumer risk is the most important one [11].…”

Section: Evaluation Of the Methods Transfermentioning

confidence: 99%

“…[8,18,20]. Table 2 summarizes the main conclusion between the comparisons of these approaches in terms of risk management.…”

Section: Evaluation Of the Methods Transfermentioning

confidence: 99%

“…As can be seen from Table 2, the only classical approaches which control the consumer risk are the equivalence ones. It has also been shown that the difference approaches are definitely not fit to the objective of analytical method transfer and should be avoided to assess the transfer [18,20,26,27]. Thus no more reference to the difference approaches will be made in the remaining of this document.…”

Section: Evaluation Of the Methods Transfermentioning

confidence: 99%

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