Analysis of USP epinephrine injections for potency, impurities, degradation products, and d-enantiomer by liquid chromatography, using ultraviolet and electrochemical detectors

Abstract

A liquid chromatographic (LC) method was adapted for the determination of epinephrine and related impurities in intravenous and cardiac injections; ultraviolet (UV) and electrochemical detectors (EC) were used in series. Epinephrine was determined and related impurities, i.e., adrenalone, epinephrine sulfonic acid, and norepinephrine, were detected directly in a small portion of the injection solution. Diastereoisomers of the epinephrine enantiomers were prepared by derivatization and determined by LC with a UV detector. The recovery of epinephrine added to epinephrine injection was 100%. The recovery of d-enantiomer from a d, l mixture was 100%. Impurities at levels < 1% were easily detected. The LC method with UV detection is faster and more convenient than the USP XX method. In addition, impurities can be detected in the same portion of sample. The procedure is stability-indicating.