Method validation in the bioanalytical laboratory

Buick, A.R.; Doig, Mira; Jeal, S.; Land, G.; McDowall, R.D.

doi:10.1016/0731-7085(90)80093-5

Cited by 132 publications

(50 citation statements)

References 4 publications

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“…4,11,12 A resposta que um determinado método bioanalítico apresenta para as diversas substâncias presentes em uma amostra é definida como seletividade, enquanto que a especificidade se baseia na habilidade que um determinado método apresenta em responder a uma única substância de interesse dentre outras presentes na amostra. A avaliação da seletividade é determinada não somente considerando a aplicação de um método, mas também a técnica instrumental a ser utilizada.…”

Section: Seletividadeunclassified

Validação em métodos cromatográficos para análises de pequenas moléculas em matrizes biológicas

Cassiano¹,

Barreiro²,

Martins³

et al. 2009

Quím. Nova

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Section: Seletividadeunclassified

Validação em métodos cromatográficos para análises de pequenas moléculas em matrizes biológicas

Cassiano¹,

Barreiro²,

Martins³

et al. 2009

Quím. Nova

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“…The guiding principles [41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57] for validation of bioanalytical methods were used as references to design the experiments. Since PGs, DiHETrEs, HETEs, EETs, and AA are endogenous compounds, the analyte-free brain matrix is not available for matrix-based method validation and there is no other proxy matrix available to mimic the complicated solid brain tissue.…”

Section: Methods Validation Design-mentioning

confidence: 99%

A liquid chromatography/mass spectrometric method for simultaneous analysis of arachidonic acid and its endogenous eicosanoid metabolites prostaglandins, dihydroxyeicosatrienoic acids, hydroxyeicosatetraenoic acids, and epoxyeicosatrienoic acids in rat brain tissue

Yue

Jansen

Strauss

et al. 2007

Journal of Pharmaceutical and Biomedical Analysis

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A sensitive, specific, and robust liquid chromatography/mass spectrometric (LC/ MS) method was developed and validated that allows simultaneous analysis of arachidonic acid (AA) and its cyclooxygenase, cytochrome P450, and lipoxygenase pathway metabolites prostaglandins (PGs), dihydroxyeicosatrienoic acids (DiHETrEs), hydroxyeicosatetraenoic acids (HETEs) and epoxyeicosatrienoic acids (EETs), including PGF 2α , PGE 2 , PGD 2 , PGJ 2 ,14,11,8,5,14,11,8,9-EET, and 5,6-EET in rat brain tissues. Deuterium labeled PGF 2α -d 4 , PGD 2 -d 4 , 15(S)-HETE-d 8 , 14,15-EET-d 8 , 11,12-EET-d 8 , 8,9-EET-d 8 , and AA-d 8 were used as internal standards. Solid phase extraction was used for sample preparation. A gradient LC/MS method using a C18 column and electrospray ionization source under negative ion mode was optimized for the best sensitivity and separation within 35 min. The method validation, including LC/MS instrument qualification, specificity, calibration model, accuracy, precision (without brain matrix and with brain matrix), and extraction efficiency were performed. The linear ranges of the calibration curves were 2-1000 pg for PGs, DiHETrEs, HETEs, and EETs, 10-2400 pg for PGE 2 and PGD 2 , and 20-2000 ng for AA, respectively.

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“…Analytes can be classified into four categories; acid, basic, neutral, and amphoteric compounds. Amphoteric analytes have both acid and basic functional groups and can, therefore, functions as cations, anions or zwitterions, depending on pH, mainly the pH is 13 [13][14][15].…”

Section: Elutionmentioning

confidence: 99%

A Review on Bioanalytical Method Development and Validation

Tijare¹,

Nt²,

Un³

2016

Asian J Pharm Clin Res

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In this review article, bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and the methods should be applied to studies in areas of human clinical and nonhuman study. Bioanalytical method employed for the quantitative estimation of drugs and their metabolites in biological media and plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic studies. The major bioanalytical role is method development, method validation, and sample analysis. Every step in the method must be investigated to decide the extent to which environment, matrix, or procedural variables can interfere the estimation of analyte in the matrix from the time of set up to the time of analysis. Techniques such as high pressure liquid chromatography (HPLC) and liquid chromatography coupled with double mass spectrometry (LCMS-MS) can be used for the bioanalysis of drugs in body. Each of the instruments has its own merits and demerits. Chromatographic methods are HPLC and gas chromatography have been mainly used for the bioanlysis of small/ large molecules, with LC/MS/MS. Linearity, accuracy, precision, selectivity, sensitivity, reproducibility, and stability are some of the regularly used parameters. In this review article, we are proposed to add some points regarding bioanalytical method development and validation parameter, beneficial to quality assurance to determine the drug, concentration and its metabolite.

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Method validation in the bioanalytical laboratory

Cited by 132 publications

References 4 publications

Validação em métodos cromatográficos para análises de pequenas moléculas em matrizes biológicas

Validação em métodos cromatográficos para análises de pequenas moléculas em matrizes biológicas

A liquid chromatography/mass spectrometric method for simultaneous analysis of arachidonic acid and its endogenous eicosanoid metabolites prostaglandins, dihydroxyeicosatrienoic acids, hydroxyeicosatetraenoic acids, and epoxyeicosatrienoic acids in rat brain tissue

A Review on Bioanalytical Method Development and Validation

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