Background: It was desired to use contemporary knowledge and technology to develop a highly selective and reliable LC-MS/MS method for teriparatide in human plasma to begin to supplant existing ELISA methodologies.
Results: The method was developed using SPE of intact teriparatide and the internal standard rat analogue parathyroid hormone fragment 1-34 from human plasma, and UPLC-MS/MS analysis. Inter- and intra-batch accuracy and precision ranged from 97.5 to 109%, and 1.78 to 12.4%, respectively. Mean analyte extraction recoveries of 80% were attained.
Conclusion: All relevant acceptance criteria were met in a procedure akin to method validation without the stability aspects, and with a basis of excellent signal stability all performance aspects of the method were unassailable.