RP-HPLC Method for Estimation and Stress Degradation Study of Paclitaxel as per ICH Guidelines
- *Corresponding Author:
- Seemi Siddiqui
B-8/45, Sector-4, Rohini, New Delhi-85
E-mail: [email protected]
Received date: July 09, 2012; Accepted date: August 19, 2012; Published date: August 24, 2012
Citation: Siddiqui S, Paliwal S, Kohli K, Siddiqui AA, Sahu K (2012) RP-HPLC Method for Estimation and Stress Degradation Study of Paclitaxel as per ICH Guidelines. J Chromat Separation Techniq 3:135 doi:10.4172/2157-7064.1000135
Copyright: © 2012 Siddiqui S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credite.
A simple, accurate, selective & reproducible validated stability indicating assay method was developed for determination of Paclitaxel in presence of its degradation products. The best separation was achieved in the C18 analytical column at ambient temperature using a mobile phase composed of acetonitrile and phosphate buffer (60:40) in isocratic mode. The flow rate was set at 1.0 ml/min and detection wavelength was 226 nm. The drug gives peak at RT 4.95 min and forced degradation studies gave two degradation products such as one peak of degradation product of alkaline hydrolysis were observed at RRT 2.941(DP II) and at RRT 0.382 (DP I) a peak for acidic hydrolysis product obtained along with the drug peak at RT 4.95. The limit of detection (LOD) and limit of quantitation (LOQ) of developed method were found to be 2 μg/ml and 10 μg/ml respectively. The validation results obtained from the analysis also reveals that the developed method is specific and selective.