Capillary electrophoresis on‐line hyphenated with mass spectrometry for analysis of insulin‐like growth factor‐1 in pharmaceutical preparations

Abstract

Insulin‐like growth factor‐1 (IGF‐1) is a 70‐amino acid single‐chain polypeptide, which has found application in diagnostics as a biomarker of growth hormone disorders and as a therapy for growth failure in children and adolescents. Due to its strong anabolic effects, it is often abused by athletes for doping purposes. Here, we developed an on‐line hyphenated method based on capillary zone electrophoresis (CZE) and triple quadrupole mass spectrometry (MS) detection with electrospray ionization (CZE–electrospray ionization source–MS [CZE–ESI–MS]) for the determination of IGF‐1 in pharmaceutical matrices. We achieved a highly efficient, accurate, repeatable, sensitive, and selective analysis of IGF‐1 with favorable migration times (<15 min). Optimized and validated CZE–ESI–MS method was successfully applied for the determination of IGF‐1 in injectable solutions (Increlex®), and its presence was also confirmed in nutritional preparations (tablets and liquid colostrum). This is the first validated CZE–ESI–MS method for the determination of IGF‐1 in pharmaceutical matrices revealing the potential of capillary electrophoresis for its use in drug quality control laboratories with benefits, such as high separation efficiency, high‐speed analysis, low sample consumption, as well as environmental and cost aspects.