Is it really necessary to validate an analytical method or not? That is the question

Rambla-Alegre, Maria; Esteve‐Romero, Josep; Carda‐Broch, Samuel

doi:10.1016/j.chroma.2011.10.050

Cited by 118 publications

(71 citation statements)

References 24 publications

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“…Therefore, the revalidation is compulsory if a parameter is modified outside the operating range. For instance, if the optimum pH of the mobile phase is 5 and the operating range is 4 and 6, the method does not need to be revalidated if the working pH is moved to 5.5, but ought to be revalidated if the working pH is changed to 7.0 [17]. The revalidation is necessary if the scope of the method has been changed or extended (e.g., applied to other matrices, incorporation of other analytes, consideration of other possible interferences, enlarging of the working range, etc.)…”

Section: Revalidationmentioning

confidence: 99%

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Validation of Analytical Methods Based on Chromatographic Techniques: An Overview

Péris-Vicente

Esteve‐Romero

Carda‐Broch

2015

Analytical Separation Science

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What Validation Is?The purpose of any analytical method is to provide consistent, reliable, and accurate data. For this reason, the performances and the limitations of the method, as well as the external influences which may modify these features, must be determined prior to its use. Validation plays a major role in achieving this goal [1,2]. The word "validation" comes from the Latin term validus, meaning worth/strong, thus suggesting that something is true, useful, and reliable [3]. The most accurate definition of validation is that provided by ISO 9000:2000 as the confirmation, by means of a thorough examination and obtaining realistic and unequivocal evidences, that the procedure is effectively applicable for its indented purpose [4].Validation is the act of proving that any approach, strategy, experimental procedure, process, laboratory staff, instrumentation, reagents, and room conditions selected for the method will function in a proper way under a fixed set of conditions. Besides, it can be used to individually evaluate the appropriateness of these factors [5]. The validation evaluates the range and conditions of applicability, and checks if every future measurement in routine analysis will provide a concentration of the analyte close enough to the true value [6]. In addition, it can also quantify the degree of coincidence of a measured concentration and the true value, by the calculation of the bias and the uncertainty associated with the result [7]. Therefore, the validation verifies if the method is suitable to be used as a quality control tool and for research support [8]. It is an essential step in method development, which must be implemented by laboratories to prove they can produce analytical data with high reliability [9].The validation consists in the determination of well-defined quality parameters: statistical (selectivity, specificity, calibration curve, linearity, calibration range, accuracy, precision, recovery, uncertainty, limit of detection, limit of quantification (LOQ), decision limit, detection capability, robustness, stability, system suitability, and comparison with other methods) [1,2,10] and operating/ economical (cross contamination, simplicity, analysis time, price per analysis, safety for laboratory staff, and environmental impact) [11,12]. The results from

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Section: Revalidationmentioning

confidence: 99%

“…The adequate method must be selected considering the available instrumentation, and preferably following this priority order [17]:…”

Section: Validation Strategiesmentioning

confidence: 99%

Validation of Analytical Methods Based on Chromatographic Techniques: An Overview

Péris-Vicente

Esteve‐Romero

Carda‐Broch

2015

Analytical Separation Science

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“…The external standard calibration method is performed when no systematic error from the matrix is suspected, while the matrix superposition method compensates for the effect of the matrix 16,17,20 .A linear correlation was obtained for the analytical curves with the external standard calibration method and matrix superposition method for both drugs -ABZ and FBZ -, with a correlation coefficient (r) exceeding 0.99. The analysis of the residue showed normal distribution of points around the line indicating that the model is adequate (Figure 3).…”

Section: Linearitymentioning

confidence: 99%

Development and Validation of the Rp-HPLC Method for Determination of Benzimidazole Carbamates in the Presence of Cyclodextrins

Rodrigues¹,

Reis²,

Katiki³

2017

Int. Res. J. Pharm.

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Liquid chromatography is the universal method to determine drugs in biological matrices and pharmaceutical products. Different strategies have been developed in order to improve the aqueous solubility and bioavailability of benzimidazoles, such as the complexation with cyclodextrins. Although extensive studies on cyclodextrins have been performed, studies on the impact of cyclodextrins on the chromatographic process are scarce. The objective of this study was to develop and validate a suitable HPLC method for the quantification of benzimidazoles carbamates (albendazole and fenbendazole) in the presence of cyclodextrins (β-cyclodextrin and hydroxypropyl-β-cyclodextrin). The retention time of the benzimidazoles and their metabolites decreases in the presence of cyclodextrins. The formation of inclusion complexes between drugs and cyclodextrins can explain the change in retention times. Hydroxypropyl-β-cyclodextrin decreased the retention time of the solute in a more pronounced way than β CD. This phenomenon can be attributed to the greater hydrophilicity of Hydroxypropyl-β-cyclodextrin, which promotes the formation of more soluble complexes and, therefore, with less affinity for the stationary phase.

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“…wartość normatywna precyzji). Podobnie jak w analizie statystycznej wyników zebranych podczas oceny precyzji metody tu również zakłada się, że wszystkie analizowane wyniki pochodzą z jednego rozkładu normalnego, innymi sło-wy -zmiana laboratorium nie ma wpływu na wynik innego niż stochastyczny [25,37].…”

Section: Wykorzystanie Wyników Badań Międzylaboratoryjnych Do Sterowaunclassified

Odtwarzalność rzeczywista, w testach PT, znormalizowanych procedur badawczych stosowanych w badaniu jakości paliw silnikowych. Część I. Badania kompetencji laboratoriów

Altkorn

2017

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Odtwarzalność rzeczywista, w testach PT, znormalizowanych procedur badawczych stosowanych w badaniu jakości paliw silnikowych. Część I. Badania kompetencji laboratoriówArtykuł ma na celu stwierdzenie, czy normatywna odtwarzalność znormalizowanych procedur badawczych, podana w normach czynnościowych badania parametrów jakościowych paliw silnikowych do silników z zapłonem iskrowym, a określona na etapie opracowywania lub nowelizacji norm czynnościowych, jest zgodna z odtwarzalnością rzeczywistą, jaka jest osiągana w praktyce przez szerokie grono użytkowników danej normy. Oceny w praktyce dokonano poprzez analizę wyników badań międzylaboratoryjnych, przeprowadzanych przez liczną grupę uczestników, w których brały udział laboratoria Zakładu Analiz Naftowych INiG -PIB w latach 2010-2016. Z uwagi na dużą liczbę uczestniczących laboratoriów i różny stopień kompetencji, uzyskana przez nie odtwarzalność rzeczywista ma wysoką wartość statystyczną. Część I opisuje problemy, które mogą wystąpić podczas organizacji badania kompetencji laboratoriów.Słowa kluczowe: norma czynnościowa, odtwarzalność, badanie kompetencji.Actual reproducibility, in PT tests, standardized testing procedures used in the testing of engine fuel quality. Part I. Proficiency testing of laboratoriesThe article seeks to ascertain whether the normative reproducibility of standardized test procedures, as set out in the functional standards for the quality testing of motor fuels for spark-ignition engines, and defined at the stage of developing or amending functional standards, is consistent with actual reproducibility achieved in practice by a wide circle of users of a given standard. Practical assessment was done by analyzing the results of interlaboratory tests carried out with the participation of a very large group of participants, amongst them the laboratories of the Department of Petroleum Analyses of the Oil and Gas Institute -National Research Institute in 2010-2016. Due to the large number of participating laboratories and the varying degrees of proficiency, the actual reproducibility achieved by them has a high statistical value. Part I describes the problems that may occur during the organization of proficiency testing of laboratories.

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Is it really necessary to validate an analytical method or not? That is the question

Cited by 118 publications

References 24 publications

Validation of Analytical Methods Based on Chromatographic Techniques: An Overview

Validation of Analytical Methods Based on Chromatographic Techniques: An Overview

Development and Validation of the Rp-HPLC Method for Determination of Benzimidazole Carbamates in the Presence of Cyclodextrins

Odtwarzalność rzeczywista, w testach PT, znormalizowanych procedur badawczych stosowanych w badaniu jakości paliw silnikowych. Część I. Badania kompetencji laboratoriów

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