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Validation of an ultrasensitive LC-MS/MS method for PTH 1-34 in porcine plasma to support a solid dose PK study
Richard G Kay1, Jonathan T Hands1, Glen Hawthorne1
1LGC, Newmarket Road, Fordham, Cambridgeshire, CB7 5WW, UK.
Background:
The bioanalysis of Teriparatide (PTH 1-34) is extremely challenging due to the low plasma concentrations present at a therapeutic level. An LC-MS/MS-based method was developed that detected PTH 1-34 at 15 pg/ml in porcine plasma, and was validated using the bioanalytical method validation guidelines.
Results:
The analytical methodology demonstrated good linearity over a range of 15-1000 pg/ml, and demonstrated good precision and accuracy. The validated method was used to support a trial comparing a solid state dose to a solution-based injection (Forteo™).
Conclusion:
The ability to quantify the peptide at low pg/ml in porcine plasma demonstrates that it is possible to develop very sensitive LC-MS/MS-based methodologies to support the bioanalysis of large peptide biotherapeutics.
