Residual Solvents in Bendamustine Hydrochloride By Headspace Chromatography Babu J. Ramesh*, Suhasini J., Vidyadhara S. Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chandramoulipuram, Chowdavaram, Guntur.(A.P.), India *Corresponding Author E-mail: ramesh.janga11@gmail.com
Online published on 2 June, 2018. Abstract There are only few published reports on determination of residual solvents in the analytical method development and there exists no detailed guidelines. Residual solvents from the process in the manufacturing of pharmaceuticals are hazardous and cause serious problems, so must be removed. This is much effort in this work is focused on the determination of analytical method for the determination of residual solvents. Bendamustine hydrochloride pure drug, various solvents, Shimadzu GC-2010 with head space auto injector and AOC-5000 with head space auto injector were used. The method development based on residual solvent properties and many trails conducted on conditions like column selection, carrier gas flow, oven temperature and diluent. A simple HS-GC method for the determination of residual solvents in Bendamustine hydrochloride using helium as the carrier gas at 3.0mL/min with DB-624 (30.0 meters X 0.53 mm ID, 3.0μm d.f. capillary) as column using FID as detector was developed. The developed method was validated and parameters were to be found within the limits of USP. The retention time for residual solvents individually and in spiked standard solution was determined. The %RSD for six injections should be NMT15%. The percentage recovery ranges from 84.57118.86%. The correlation coefficient was R2 ≥ 0.999. The method was validated for repeatability, linearity, limit of detection, limit of quantification and recovery according to the International Conference on Harmonization guidelines. The method validation results indicate that the method is accurate, precise, linear and sensitive for solvents assessed. Excellent results were obtained, within the globally accepted validation reference values, particularly taking into account the low concentration levels investigated. Top Keywords Validation, Residual solvents, HS-GC and Bendamustine hydrochloride. Top |