CRCU

Chemical Research in Chinese Universities ›› 2009, Vol. 25 ›› Issue (4): 433-438.

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Quantitative Determination of Adrenaline Hydrochloride Injection and Noradrenaline Bitartrate Injection by a New HPLC Method via Substitute for Reference Substance

XIE Yuan-chao1,2*, HUANG Hai-wei3, ZHANG Qi-ming3 and JIN Shao-hong3   

  1. 1. Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, P. R. China;
    2. Shandong Provincial Institute for Drug Control, Jinan 250101, P. R. China;
    3. National Institute for Control of Pharmaceutical and Biological Products, Beijing 100050, P. R. China
  • Received:2009-03-10 Revised:2009-03-17 Online:2009-07-25 Published:2009-10-16
  • Contact: XIE Yuan-chao. E-mail: sdxyc@yahoo.com.cn

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Abstract:

An HPLC method for quantitative determination of adrenaline hydrochloride injection and noradrenaline bitartrate injection was established and validated with a substitute for the reference substance. Phenylephrine hydrochloride was selected as the substitute for the reference substance of adrenaline and noradrenaline bitartrate. The correction factor of phenylephrine hydrochloride with respect to the reference substance of adrenaline and noradrenaline bitartrate was determined under defined conditions. Adrenaline hydrochloride injection and noradrenaline bitartrate injection were quantified by assaying phenylephrine hydrochloride and a correct factor. The results indicate that the HPLC method with the substitute for reference substance was reliable and feasible for quantitative determination of drugs.

Key words: Substitute for reference substance; Correction factor; Adrenaline; Noradrenaline bitartrate; Phenylephrine hydrochloride; HPLC