The importance of matrix effect and its determination for
LC–MS–MS based bioanalytical methods is discussed in
subsequent sections. There are no specifications presented
in ANVISA guidelines for evaluation of matrix effect.
However, US FDA requires the demonstration of matrix
effect during validation ‘to ensure that precision, selectivity
and sensitivity would not be compromised’. In addition,
it recommends comparison of standard curve in biological
fluids to that of standards prepared in buffer and parallelism
of diluted study samples with diluted standards for
determination of matrix effects.