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Development and Validation of a Novel Reverse Phase HPLC for Determination of Aloperine in Aloperine Tablets

WANG Hua, ZHENG Li, WANG Zhan, ZHANG Yong-qiang, WU Feng-lan*   

  1. Department of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing 100083, China
  • Received:2003-08-29 Revised:2003-11-10 Online:2003-12-15 Published:2003-12-15
  • Contact: WU Feng-lan*

Abstract: Aim To develop a reverse phase HPLC method for the determination of aloperine, an alkaloid that is newly extracted from Sophora alopecuraides and has shown wide pharmacological effects including antibacterial and antiinflamma-tory actions. Methods The samples were analyzed on a ODS column with methanol-water-triethylamine (3:97:0.1 V/V) as a mobile phase. The flow rate was 1.0 mL· min-1, and UV detection wavelength 205 nm. Results Linear regression equation was A = 1.6920C + 1.7455 (r2 = 0.9999, n = 5 ) in concentratins ranging from 20 to 120 μg·mL-1. The recover-ies were 101.2+ 1.46 % at 80 μg·mL-1, 100.5 +0.75% at 100 μg·mL-1, and 100.7 + 1.10% at 120 μg·mL-1, respectively, and the precisions of aloperine within or between run were from 0.80% to 1.98% ( n = 5). The relative cont-ents of aloperine in three lots of tablets were 101.59 + 1.38%, 98.46 + 0.23%, and 99.41 + 1.09% ( n = 3). Conclusion The newly developed reverse phase HPLC method is simple and useful for daily assay of aloperine tablets and can overcome the interference from excipient and other alkaloids in titration and UN detection.

Key words: aloperine, aloperine, aloperine tablets, aloperine tablets, RP HPLC, RP HPLC

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