Synthetic peptides have emerged as promising drug candidates for a wide variety of disease due to their low toxicity and broad range of activity, resulting in one of the fastest growing market in the biopharmaceutical industry. The standard method for synthesizing peptide, solid-phase peptide synthesis (SPPS), often introduces process and product related impurities which add to the complexity of analysis when characterizing synthesized products. Quality control of synthetic peptide products is essential to assure drug products are safe and efficacious.
Reversed-phase LC with optical detection is the common quality control method for synthetic peptides. However, optical detection limits may not be sufficient in the assessment of low abundant impurities that pose a risk to patient safety. To this end, methods that can increase the sensitivity and confidence of impurity analysis are highly desirable. As an orthogonal technique, mass detection can effectively increase sensitivity and specificity, in turn providing a higher level of assurance.
In this study, we present a workflow with simultaneous acquisition of optical and mass data that enables identification of a target peptide, eledoisin, and its impurities. This work demonstrates the improved productivity and confidence for impurity profiling of synthetic peptides by combining straightforward mass detection and optical detection in a single workflow.