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A RP-HPLC method for determination of paclitaxel in its solid dispersion

Xiang-Rui Liu, Ke-Chun Wu, Chun-Hui Zhang, Xuan Zhang*, Qiang Zhang   

  1. Department of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing 100083, China
  • Received:2006-12-15 Revised:2007-05-10 Online:2007-06-15 Published:2007-06-15
  • Contact: Xuan Zhang*

Abstract: Aim To develop and validate a RP-HPLC method for the analysis of paclitaxel in a solid dispersion. Methods Paclitaxel and the internal standard norethisterone were separated using a Phenomenex ODS 3 column and monitored at a wavelength at 227 nm. The isocratic mobile phase consisting of methanol-acetonitrile-water (40:30:30, V/V) was pumped at a flow-rate of 1.0 mL·min–1. The dissolution studies were performed according to published studies. Results Under these chromatographic conditions, the calibration curve was linear in the range of 4–40 μg·mL–1 with the correlation coefficient of 0.9999. The mean recovery was 98.42 % (RSD = 1.19%). At the 60 min time point, the dissolution of paclitaxel from the solid dispersion was nearly 100 %, however, the original form of paclitaxel was about 30%. Conclusion The method was proven to be specific, accurate and precise for determining the dissolution of paclitaxel from solid dispersion.

Key words: Paclitaxel, Paclitaxel, Solid dispersion, Solid dispersion, RP-HPLC, RP-HPLC

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