Validation of Analytical Test Methods

Bretnall, Alison E.; Clarke, Graham S.

doi:10.1016/b978-0-12-375680-0.00011-5

Cited by 8 publications

(7 citation statements)

References 21 publications

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“…The calibration curves plotted were linear over the concentration range of 62.5 to 1000 μg/mL. LOD and LOQ values were found to be reliable for the method according to Bretnall et al [ 49 ]. In addition, the precision of HPLC method regarding reproducibility and repeatability was satistacfory as indicated by the relative standard deviation (RSD) not greater than 5.0% [ 50 ] of peak area and retention time by intraday and interday analyses.…”

Section: Resultsmentioning

confidence: 94%

Inhibitory Effect of Triterpenoids from Dillenia serrata (Dilleniaceae) on Prostaglandin E2 Production and Quantitative HPLC Analysis of Its Koetjapic Acid and Betulinic Acid Contents

et al. 2015

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The crude methanol extracts and fractions of the root and stem barks of Dillenia serrata Thunb. showed 64% to 73% inhibition on the production of prostaglandin E2 (PGE2) in lipopolysaccharide-induced human whole blood using a radioimmunoassay technique. Three triterpenoids isolated from the root bark of the plant, koetjapic (1), 3-oxoolean-12-en-30-oic (2), and betulinic (3) acids, exhibited significant concentration-dependent inhibitory effects on PGE2 production with IC50 values of 1.05, 1.54, and 2.59 μM, respectively, as compared with the positive control, indomethacin (IC50 = 0.45 μM). Quantification of compounds 1 and 3 in the methanol extracts and fractions were carried out by using a validated reversed-phase high performance liquid chromatography (RP-HPLC) method. The ethyl acetate fraction of the stem bark showed the highest content of both compound 1 (15.1%) and compound 3 (52.8%). The strong inhibition of the extracts and fractions on cyclooxygenase-2 (COX-2) enzymatic activity was due to the presence of their major constituents, especially koetjapic and betulinic acids.

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Section: Resultsmentioning

confidence: 94%

Inhibitory Effect of Triterpenoids from Dillenia serrata (Dilleniaceae) on Prostaglandin E2 Production and Quantitative HPLC Analysis of Its Koetjapic Acid and Betulinic Acid Contents

et al. 2015

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“…These parameters should be determined at three concentrations: low (near the LLOQ or under the permitted limit), medium (near the middle of the calibration range or permitted limit), and high (near the ULOQ or over the permitted limit) [10,15]. Each level is analyzed by three to six replicates.…”

Section: Accuracy and Precisionmentioning

confidence: 99%

“…This iterative process of development and evaluation should follow until the validation parameters meet the fixed requirements; then the method is fit for purpose and can proceed. To facilitate the validation procedure, a thorough validation protocol should be written, preferably in a step-by-step format, at the beginning of the process, by considering the following points [15,55]:…”

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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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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“…Specificity is one of the most important characteristics of an analysis method. When the criteria for specificity are not met, this often indicates that the method is not sufficiently developed [ 33 ]. YA was well separated from the adjacent peaks and was identified by comparison of the retention time and cochromatography with standard YA ( Figure 3 ).…”

Section: Resultsmentioning

confidence: 99%

Quantification of Multifunctional Dipeptide YA from Oyster Hydrolysate for Quality Control and Efficacy Evaluation

Xie

Kang

et al. 2018

BioMed Research International

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YA is an angiotensin-I-converting enzyme- (ACE-) inhibitory peptide from oyster hydrolysate with antihypertensive activity. Its antioxidant and anti-inflammatory activity were investigated in this study. YA can dose-dependently quench DPPH and ABTS radical and inhibit lipopolysaccharide-induced nitric oxide in RAW 264.7 cells. YA is a multifunctional peptide and was selected as an indicator for quality control and efficacy evaluation of oyster hydrolysate. A practical HPLC/UV assay for YA quantification was developed and validated. It was proved to be accurate and reliable, according to parameters such as specificity, linearity, precision, and accuracy. The quantity results of YA showed that the stage of enzymatic hydrolysis was a critical control point for quality control; the efficacy of oyster hydrolysate can be enhanced after digested in the gastrointestinal tract due to the release of YA by brush border peptidases. Therefore, YA from oyster hydrolysate is a potential bioactive ingredient for functional foods to combat hypertension.

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Validation of Analytical Test Methods

Cited by 8 publications

References 21 publications

Inhibitory Effect of Triterpenoids from Dillenia serrata (Dilleniaceae) on Prostaglandin E2 Production and Quantitative HPLC Analysis of Its Koetjapic Acid and Betulinic Acid Contents

Inhibitory Effect of Triterpenoids from Dillenia serrata (Dilleniaceae) on Prostaglandin E2 Production and Quantitative HPLC Analysis of Its Koetjapic Acid and Betulinic Acid Contents

Validation of Analytical Methods Based on Chromatographic Techniques: An Overview

Quantification of Multifunctional Dipeptide YA from Oyster Hydrolysate for Quality Control and Efficacy Evaluation

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