Development and validation of stability indicating HPLC method for determination of adrenaline tartrate

Abstract

Epinephrine (Adrenaline) is a lifesaving medication of the treatment of anaphylaxis and cardiac resuscitation. For out of hospital emergency treatment, some prefilled syringe and auto-injector device has been developed and prescribed to patients. In order to predict shelf life of the developed device, a stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated for determine the amount of adrenaline tartrate. Separation was carried out using a 2.6 µm Kinetex Biphenyl column, with 50 mM sodium dihydrogen phosphate adjusted to pH 3.0 as a mobile phase and a flow rate of 0.5 mL/min, at 25 °C and detected at 279 nm. Parameters for the validation included accuracy, precision, linearity, and limit of quantitation and detection. The developed HPLC method was precise, with lower than 2% relative standard deviation. The accuracy of the method, represented by recovery studies ranged between 99.25% and 101.81%. Stress testing was carried out to demonstrate specificity of the method. The developed method could separate the potential degradation products from the adrenaline tartrate peak. This proposed method was suitable and practical for analysis the content of adrenaline tartrate in pharmaceutical products and could be of benefit for prediction shelf life of adrenaline tartrate in developed auto-injector device. Keywords: Adrenaline, Epinephrine, HPLC, Stability-indicating method (SIM)