Aim: A rapid UPLC-MS/MS method for the determination of tamoxifen (TAM), N-desmethyltamoxifen, 4-hydroxytamoxifen and endoxifen in human plasma was validated, after a simple protein precipitation.
Materials and methods: The analysis was achieved on a C18 analytical column, using a gradient elution with a mobile phase of water and acetonitrile for 4.5 min.
Results: The validated method demonstrated good linearity between 1 and 500 ng/ml for TAM and N-desmethyltamoxifen; between 0.2 and 100 ng/ml for endoxifen and between 0.1 and 50 ng/ml for 4-hydroxytamoxifen. The method also provided satisfactory results in terms of within day and between day imprecisions and accuracy, and also in terms of time stability and specificity.
Conclusion: The method is applied routinely for TAM monitoring from patients undergoing therapy.
Keywords: 4-hydroxytamoxifen; N desmethyl tamoxifen; UPLC–MS/MS; analytical method; endoxifen; plasma; tamoxifen; therapeutic drug monitoring; validation method.