Analytical and bioanalytical methods

Development and validation of HPLC-UV, DAD, MS and MS/MS methods to quantify drugs in formulations and biological matrices.

Every pharmacokinetic conclusion depends on correctly measuring how much drug is in a sample. In this line, PKBio develops, validates and applies analytical methods for formulations and bioanalytical methods for biological matrices such as plasma.

What we do

  • Method development by high-performance liquid chromatography (HPLC) with ultraviolet (UV), diode array (DAD) and mass spectrometry (MS and MS/MS) detection.
  • Validation according to regulatory guidelines: selectivity, linearity, precision, accuracy, matrix effect and stability.
  • Application of validated methods in solubility, formulation stability and animal pharmacokinetic studies.

Why it matters

Reliable methods are the foundation of the data that feed pharmacokinetic models and of conclusions about drug quality.