Development of Supercritical Fluid (Carbon Dioxide) Based Ultra Performance Convergence Chromatographic Stability Indicating Assay Method for the Determination of Clofarabine in Injection

Authors: Venkata Narasimha Rao Ganipisetty, a Jalandhar D, a Gnana dev G, a Rajendar Bandari, a Manoj P, a Dhananjay Da, Venkata Nadh R

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 mm) by using methanol as a cosolvent 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.

Comments: 6 Pages. OK

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[v1] 2019-05-19 05:40:04

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