Small Molecule Pharmaceutical
- Highly sensitive, validated and ready to use teriparatide LC/MS method - Simple single step SPE method - Linear dynamic range suitable for pK studies which ranged between 5 pg/mL to 300 pg/mL - Consistent, reproducible, and precise recovery
Teriparatide, a mid size peptide shown in Fig. 1, is a recombinant parathyroid hormone used for the treatment of osteoporosis. Daily injections of teriparatide stimulates new bone formation leading to increased bone mineral density (1) . The subcutaneous dose of teriparatide results in very low plasma levels characterized by rapid absorption and elimination, thus requires a highly sensitive method for estimation of analyte in human plasma. In addition, the critical challenges in method development are poor ionization, non- specific adsorption, low recovery and predominantly carryover issues. This motivated us to develop a highly sensitive quantification method for determination of teriparatide in human plasma using Shimadzu LCMS-8060 triple quadrupole mass spectrometry coupled with NexeraTM X2 UHPLC. Shimadzu Application Development Centre (ADC-SAIP), Mumbai has developed and validated a rapid, simple, sensitive and novel method with the lowest limit of quantification (LLOQ) of 5 pg/mL. Precision and accuracy (PA) of the analyte were evaluated at lowest limit of quantification quality control (LLOQ QC), low quality control (LQC), middle quality control (MQC) and high quality control (HQC) samples.
October 30, 2025 GMT