Quantifying vemurafenib in dried blood spots using high-performance LC-MS/MS.

Abstract

CONCLUSION

This assay met all predefined validation criteria and is considered suitable to quantify vemurafenib in dried blood samples.

BACKGROUND

To further investigate the pharmacokinetics of vemurafenib and to support therapeutic drug monitoring an LC-MS/MS method was developed and validated for the quantification of vemurafenib in dried blood spots.

RESULTS

Vemurafenib was extracted from the dried blood spots by methanol:acetonitrile (50:50, v/v) and separated on a C18 column with gradient elution and analyzed with triple quadrupole mass spectrometry in positive ion mode. The validated calibration range is linear from 1 to 100 µg/ml. Intra- and inter-assay accuracies and precisions were within ±13.6% and ≤6.5%. The applicability of the assay was tested by analyzing dried blood spots samples of melanoma patients receiving vemurafenib.