Development and Validation of RP-HPLC Method for Analysis of Novel Self-emulsifying Paclitaxel Formulation.
A stability indicating liquid chromatography method was developed and validated for quantitation of aliquots of the in-vitro drug release and ex-vivo permeation study for paclitaxel in a new pharmaceutical dosage form. The reverse phase high performance liquid chromatography separation was achieved on C18 LiChrospherï¢100 (250x4.6mm, 5 μm particle size) using a mobile phase of acetonitrile: water (60:40 v/v) at a flow rate of 1.0 mL/min. The injection volume was 20 μL and elute was analyzed with UV detector set at a wavelength 227 nm. The proposed method was validated for specificity, linearity, precision, accuracy and robustness. The calibration curve of paclitaxel was observed to be linear in the range of 0.1-100 μg/ml with r2=0.999. It was found to be simple, specific, precise, accurate, and reproducible with limit of detection and quantitation 0.026 μg/ml and 0.085 μg/ml respectively. The method was suitable for the quality control of developed paclitaxel formulation, to quantify the drug and its degradation product formed under stress conditions as well as its stability assessment under accelerated conditions used to determine shelf life.
Javed Ahmad, Kanchan Kohli, Showkat R Mir, and Saima Amin