Author(s): Venkata Narasimha Rao Ganipise, Jalandhar D, Venkata Narasimha Rao Ganipise, Rajendar Bandari, Manoj P
The present study reports the development and validation of a stability indicating assay method for clofarabine in injection on a UPC2™ (ultra performance convergence chromatography) instrument, which utilizes the unrealized potential of supercritical fluid chromatography. The use of UPC2™ provides a single viable technique that is a sustainable, reduced cost, and green technology that lowers the use of organic solvents. Based on this advantage, we explored a simple and robust method in order to increase sample throughput and productivity to quantify clofarabine in the presence of its potential impurities and other degradants. The separation was achieved on a BEH-2-ethyl pyridine (BEH 2EP) column (100 mm × 3.0 mm I.D. with an average pore diameter of 1.7 μm) by using methanol as a co-solvent and carbon dioxide as a mobile phase in the ratio of 30 : 70. The detection is carried out at a wavelength of 254 nm. We are able to achieve the separation of clofarabine from its potential impurities and other degradants in less than 6 minutes with a low amount of solvent consumption. The new method is validated in accordance with the ICH-guidelines and exhibited good intra- and inter-day precision, accuracy and linearity (r2 ≥ 0.999) over a range of 50% to 150% of target concentration.