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标题：Development and validation of stability indicating HPLC method for determination of adrenaline tartrate
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作者：Sumet Kongkiatpaiboon ; Sumet Kongkiatpaiboon ; Nongnaphat Duangdee 等
期刊名称：Journal of King Saud University - Science
印刷版ISSN：1018-3647
出版年度：2019
卷号：31
期号：1
页码：48-51
DOI：10.1016/j.jksus.2017.05.016
语种：English
出版社：Elsevier
摘要：AbstractEpinephrine (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 2.6µm Kinetex Biphenyl column, with 50mM sodium dihydrogen phosphate adjusted to pH 3.0 as a mobile phase and a flow rate of 0.5mL/min, at 25°C and detected at 279nm. 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.
关键词：Adrenaline;Epinephrine;HPLC;Stability-indicating method (SIM)