UHPLC determination of paclitaxel in polydipeptide paclitaxel
10.13220/j.cnki.jipr.2014.06.017
- Author:
Jing-Feng LI
1
Author Information
1. Guangxi Medical University
- Publication Type:Journal Article
- Keywords:
Determination;
Paclitaxel;
Poly dipeptide paclitaxel;
UHPLC
- From:
Journal of International Pharmaceutical Research
2014;41(6):703-706
- CountryChina
- Language:Chinese
-
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.
