Estimation of the uncertainty associated with the results based on the validation of chromatographic analysis procedures: Application to the determination of chlorides by high performance liquid chromatography and of fatty acids by high resolution gas chromatography

Quintela, M.; Báguena, J.; Gotor, Gemma; Blanco, Ma José; Broto, F.

doi:10.1016/j.chroma.2011.11.064

Cited by 15 publications

(15 citation statements)

References 5 publications

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“…The tolerances were established according to the exigencies of the accreditation entity (ENAC) auditors, who determined the limits as necessary to consider the analysis method validated.The knowledge of the error contributions to the whole analytical process is essential to obtain a proper validation of the method(Quintela et al, 2012). There are two models widely used in the uncertainty calculation of an analytical method (Eurachem/CITAC Guide CG4, 2004; ISO/IEC guide 98 Part, 1, 2009; ISO/IEC guide 98 Part 2 and Part 3, 2008): The first one is the "uncertainty propagation" and is based on a theoretical calculation where the uncertainty in every single step of the method is estimated and finally combined in an unique uncertainty.…”

mentioning

confidence: 99%

Development and validation of an ionic chromatography method for the determination of nitrate, nitrite and chloride in meat

López-Moreno¹,

Perez²,

Urbano³

2016

Food Chemistry

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confidence: 99%

Development and validation of an ionic chromatography method for the determination of nitrate, nitrite and chloride in meat

López-Moreno¹,

Perez²,

Urbano³

2016

Food Chemistry

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“…An expanded uncertainty budget was constructed for diltiazem in pharmaceutical preparations by the RP-HPLC-PDA method according to previously reported procedures [26, 30–32]. …”

Section: Methodsmentioning

confidence: 99%

Validation and Uncertainty Estimation of an Ecofriendly and Stability-Indicating HPLC Method for Determination of Diltiazem in Pharmaceutical Preparations

Sadeghi

Navidpour

Bayat

et al. 2013

Journal of Analytical Methods in Chemistry

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A green, simple, and stability-indicating RP-HPLC method was developed for the determination of diltiazem in topical preparations. The separation was based on a C18 analytical column using a mobile phase consisted of ethanol: phosphoric acid solution (pH = 2.5) (35 : 65, v/v). Column temperature was set at 50°C and quantitation was achieved with UV detection at 240 nm. In forced degradation studies, the drug was subjected to oxidation, hydrolysis, photolysis, and heat. The method was validated for specificity, selectivity, linearity, precision, accuracy, and robustness. The applied procedure was found to be linear in diltiazem concentration range of 0.5–50 μg/mL (r 2 = 0.9996). Precision was evaluated by replicate analysis in which % relative standard deviation (RSD) values for areas were found below 2.0. The recoveries obtained (99.25%–101.66%) ensured the accuracy of the developed method. The degradation products as well as the pharmaceutical excipients were well resolved from the pure drug. The expanded uncertainty (5.63%) of the method was also estimated from method validation data. Accordingly, the proposed validated and sustainable procedure was proved to be suitable for routine analyzing and stability studies of diltiazem in pharmaceutical preparations.

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“…Thus, estimating the measurement uncertainty for each matrix studied is important to ensure the quality of the analytical results and to demonstrate the suitability of the analytical method (Boleda, Galceran, & Ventura, 2013). Different procedures have been applied to calculate the measurement uncertainty associated with analyses of antibiotics (Borecka et al, 2013), chlorides and fatty acids (Quintela, B aguena, Gotor, Blanco, & Broto, 2012), ochratoxin A (Fernandes, Barros, & Câmara, 2013), pharmaceuticals (Boleda et al, 2013), pesticides, polychlorinated biphenyls and polycyclic aromatic hydrocarbons (Aslan-Sungur, Gaga, & Yenisoy-Karakas, 2014;Kmell ar et al, 2008;Planas, Puig, Rivera, & Caixach, 2006) in environmental and food matrices. However, some of these models require certified reference material, which is not always available.…”

Section: Introductionmentioning

confidence: 99%

In-house method validation, estimating measurement uncertainty and the occurrence of fumonisin B1 in samples of Brazilian commercial rice

2016

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a b s t r a c tFumonisin B 1 was investigated in samples of rice intended for human consumption, including polished parboiled rice, whole grain rice and whole grain parboiled rice. Until the present, no studies on the occurrence of fumonisin B 1 have been performed on these types of rice that are commercially available in the south-eastern region of Brazil. A careful intralaboratory validation was carried out to demonstrate the fitness-of-purpose of the applied method for determining fumonisin B 1 in the three studied rice types.The performance criteria e selectivity, reliable limits of detection (50 mg kg À1 ) and quantification (100 mg kg À1 ), linearity (range 100e2500 mg kg À1 ), precision (RSD values 17.0%) and recovery (71.7 e112.0 %) were evaluated, and the expanded measurement uncertainty was estimated by using the data obtained from precision and recovery experiments. Matrix-matched calibration standards were employed to quantify the mycotoxin levels in the rice samples, in which the residual normality, homoscedasticity and independence were confirmed. In addition, the measurement uncertainty values are consistent with the maximum acceptable uncertainty established by European Union regulation for analytical methods for controlling mycotoxins in foodstuffs. Among the thirty-one commercial samples of rice analysed in the present study, five samples presented detectable levels of the mycotoxin, and these levels ranged from 64.8 to 163.0 mg kg À1 .

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Estimation of the uncertainty associated with the results based on the validation of chromatographic analysis procedures: Application to the determination of chlorides by high performance liquid chromatography and of fatty acids by high resolution gas chromatography

Cited by 15 publications

References 5 publications

Development and validation of an ionic chromatography method for the determination of nitrate, nitrite and chloride in meat

Development and validation of an ionic chromatography method for the determination of nitrate, nitrite and chloride in meat

Validation and Uncertainty Estimation of an Ecofriendly and Stability-Indicating HPLC Method for Determination of Diltiazem in Pharmaceutical Preparations

In-house method validation, estimating measurement uncertainty and the occurrence of fumonisin B1 in samples of Brazilian commercial rice

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