PK/PD HPLC Method Development
I.B.S. focuses on the development of PK/PD HPLC assays with use of pre-column chemical derivatization and conventional HPLC-FLD or HPLC-UV equipment. Such approach is an ideal choice for biotech start-up companies since their primary requirements to a PK/PD assay are cost-effectiveness and robustness, along with necessary LOQ and specificity.
Compared to widely used HPLC-MS approaches applied in development of PK/PD HPLC assays, HPLC-FLD with pre-column chemical derivatization possesses a number of distinct advantages.
1. There is no need in sophisticated and expensive 2D-HPLC-MS equipment since everything can be done using conventional HPLC-FLD or HPLC-UV equipment.
2. HPLC-FLD with pre-column chemical derivatization presents robust and cost-effective solution best suited for routine assays for trace level determination of pharmaceutical residues in biological samples.
3. HPLC-FLD provides an effective way to avoid matrix effects, which are very commonly found in analysis of biological samples. As a result, this approach gives the method specificity comparable to HPLC-MS, along with better LOQ and linearity.
Better LOQ follows from the superior sensitivity of FLD detection; in turn, better linearity is due to the fact that matrix effects in HPLC-FLD are unable to influence the detector response as distinct from HPLC-MS case.