ABSTRACT
Objective To establish an ultra-high-performance liquid chromatograph(UHPLC)method for the determination of paclitaxel (PTX)in polydipeptide paclitaxel (PDP)preparation. Methods PDP preparation was dissolved in deionized water (DIW) and degraded by 2.0 mol/L sodium hydroxide solution. The concentration of paclitaxel was calculated indirectly by its degradation product. The separation was achieved on an Agilent SB C18 column(2.1 mm × 50 mm,1.8μm). Elution was carried out using a mobile phase consisting of acetonitrile-water (10 ∶ 90,V/V)at the flow rate of 0.2 ml/min. UV detection wavelength was performed at 240 nm and reference wavelength was 360 nm. The temperatures of autosampler and column were thermostated at 15℃(± 0.5℃)and 40℃(± 0.5℃),respectively. The injection volume was 2 μl. Results The relationship between the concentration of paclitaxel (0.31-5.00 mg/ml)and the peak area of its degradation product was in good linearity (r=0.9992,n=5). Total amount of paclitaxel in different batches of PDP preparation was in the range of 26.77-33.19 mg per vial. Conclusion The method is accurate, rapid,reproducible and suitable for the analysis of paclitaxel in PDP preparation.
ABSTRACT
Objective: To establish an ultra-high-performance liquid chromatograph (UHPLC) method for the determination of paclitaxel (PTX) in polydipeptide paclitaxel (PDP) preparation. Methods: PDP preparation was dissolved in deionized water (DIW) and degraded by 2.0 mol/L sodium hydroxide solution. The concentration of paclitaxel was calculated indirectly by its degradation product. The separation was achieved on an Agilent SB C18 column (2.1 mm × 50 mm, 1.8 μm). Elution was carried out using a mobile phase consisting of acetonitrile-water(10:90, V/V) at the flow rate of 0.2 ml/min. UV detection wavelength was performed at 240 nm and reference wavelength was 360 nm. The temperatures of autosampler and column were thermostated at 15°C (± 0.5) and 40°C (± 0.5°C), respectively. The injection volume was 2 μl. Results: The relationship between the concentration of paclitaxel (0.31-5.00 mg/ml) and the peak area of its degradation product was in good linearity (r = 0.9992, n= 5). Total amount of paclitaxel in different batches of PDP preparation was in the range of 26.77-33.19 mg per vial. Conclusion: The method is accurate, rapid, reproducible and suitable for the analysis of paclitaxel in PDP preparation.