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Development of an HPLC-UV method for the determination of ethaselen in its injection formulation

Su Chen, Ping Song, Ying Wang, Qi-Zhi Hu, Xuan Zhang*, Qiang Zhang   

  1. 1. Department of Pharmaceutics, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing 100191, China
    2. State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing 100191, China
    3. Department of Pharmaceutics, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China
  • Received:2012-03-07 Revised:2012-05-20 Online:2012-06-25 Published:2012-06-25
  • Contact: Xuan Zhang*

Abstract:

A novel ethaselen injection formulation has been developed in our laboratory. The objective of the present study was to establish and validate a high performance liquid chromatography (HPLC) method for the determination of ethaselen in its injection formulation. Analysis was performed on an ODS column with isocratic elution at 40 °C. Mobile phase was consisted of 0.01% phosphoric acid and methanol (60:40, v/v). The detection wavelength was set at 320 nm and the flow rate was 1.0 mL/min. The results showed that the calibration curves of ethaselen were linear in the range of 10-50 µg/mL (r2 = 0.9999). The limit of detection for ethaselen was 100 ng/mL. The average recovery of ethaselen was 100.14%. The labeled content of ethaselen in its injection formulation was in the range of 102%-103% of the measured content. In conclusion, this method was stable and reproducible, thus providing a useful tool for the routine analysis of this novel ethaselen injection formulation.

Key words: Ethaselen, Injection, HPLC, Content

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