Validation of an Ultrasensitive LC–MS/MS Method for Pth 1–34 in Porcine Plasma to Support A Solid Dose PK Study
2015; Future Science Ltd; Volume: 7; Issue: 12 Linguagem: Inglês
10.4155/bio.15.75
ISSN1757-6199
AutoresRichard G. Kay, Jonathan T Hands, Glen Hawthorne, Scott Constable, Martin Grosvenor, Johannah A Sharman,
Tópico(s)Pharmaceutical studies and practices
ResumoBackground: 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.
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