Are analysts doing method validation in liquid chromatography?

Ruiz-Ángel, M.J.; Garcı́a-Alvarez-Coque, M.C.; Berthod, Alain; Carda‐Broch, Samuel

doi:10.1016/j.chroma.2014.05.052

Cited by 20 publications

(16 citation statements)

References 191 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Several researchers also made their contribution to this topic [26]. The first report about the elaboration and processing of reliable drug products was the "Current Good Manufacture Practices," developed by the FDA in 1971.…”

Section: Validation Historymentioning

confidence: 99%

“…Accuracy and trueness, while with a different meaning [1], are interchangeably used in the literature [26], and "accuracy" is the preferred term (see Section 13.10). Accuracy/trueness is the closeness between the concentration provided by the analytical assay (calculated from the peak area through the calibration curve) and the true value [13].…”

Section: Accuracy and Precisionmentioning

confidence: 99%

See 1 more Smart Citation

Validation of Analytical Methods Based on Chromatographic Techniques: An Overview

Péris-Vicente

Esteve‐Romero

Carda‐Broch

2015

Analytical Separation Science

View full text Add to dashboard Cite

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

show abstract

Section: Validation Historymentioning

confidence: 99%

Section: Accuracy and Precisionmentioning

confidence: 99%

Validation of Analytical Methods Based on Chromatographic Techniques: An Overview

Péris-Vicente

Esteve‐Romero

Carda‐Broch

2015

Analytical Separation Science

View full text Add to dashboard Cite

show abstract

“…Others are specific or chromatography techniques [11,[15][16][17][18]. By this way, parameters for method validation have been defined in different working groups and committees at national and international levels.…”

Section: Analytical Validation: Performance Parametersmentioning

confidence: 99%

Harmonization of the quantitative determination of volatile fatty acids profile in aqueous matrix samples by direct injection using gas chromatography and high-performance liquid chromatography techniques: Multi-laboratory validation study

Raposo

Borja

Cacho

et al. 2015

Journal of Chromatography A

View full text Add to dashboard Cite

A b s t r a c tThe performance parameters of volatile fatty acids (VFAs) measurements were assessed for the first time by a multi-laboratory validation study among 13 laboratories. Two chromatographic techniques (GC and HPLC) and two quantification methods such as external and internal standard (ESTD/ISTD) were combined in three different methodologies GC/ESTD, HPLC/ESTD and GC/ISTD. Linearity evaluation of the calibration functions in a wide concentration range (10-1000 mg/L) was carried out using different statistical parameters for the goodness of fit.Both chromatographic techniques were considered similarly accurate. The use of GC/ISTD, despite showing similar analytical performance to the other methodologies, can be considered useful for the harmonization of VFAs analytical methodology taking into account the normalization of slope values used for the calculation of VFAs concentrations. Acceptance criteria for VFAs performance parameters of the multi-laboratory validation study should be established as follows: (1) instrument precision (RSDINST≤ 1.5%); (2) linearity (R 2 ≥ 0.998; RSDSENSITIVITY≤ 4%; REMAX≤ 8%; REAVER≤3%); (3) precision (RSD ≤ 1.5%); (4) trueness (recovery of 97-103%);(5) LOD (≤3 mg/L); and (6) LOQ (10 mg/L).

show abstract

“…A validation study must be conducted, as far as possible, considering all the effects that can be involved during the normal use of the method. Furthermore, the experiments must be performed, and the results must be taken, registered and processed to calculate the values of each studied parameter [46,47].…”

Section: Methodsmentioning

confidence: 99%

“…A methodical understanding about all the aspects involving validation is essential to its correct implementation. The adequate guide must be carefully selected, on the basis of the geographic zone of application, the objective of the analysis, matrix and analyte [47]. ).…”

Section: Methodsmentioning

confidence: 99%

Análisis de quinolonas en alimentos de origen animal mediante cromatografía líquida micelar

Cherif¹

View full text Add to dashboard Cite

Are analysts doing method validation in liquid chromatography?

Cited by 20 publications

References 191 publications

Validation of Analytical Methods Based on Chromatographic Techniques: An Overview

Validation of Analytical Methods Based on Chromatographic Techniques: An Overview

Harmonization of the quantitative determination of volatile fatty acids profile in aqueous matrix samples by direct injection using gas chromatography and high-performance liquid chromatography techniques: Multi-laboratory validation study

Análisis de quinolonas en alimentos de origen animal mediante cromatografía líquida micelar

Contact Info

Product

Resources

About