Development and validation of stability indicating assay method fornaratriptan by ultra performance liquid chromatography

摘要

A novel stability-indicating ultra-performance liquid chromatographic assay method was developed and validated for Naratriptan and its degradant products. An isocratic UPLC method was developed to separate the drug from the degradation products, using an Acquity UPLC BEH C18 (50mm x 2.1 mm). Mixture of water : acetonitrile (pH3.4) (60:40) was used as mobile phase. The flow rate was kept 0.3 mL min-1 and the detection was carried out at 224 nm. The linearity of the proposed method was investigated in the range of 10-50μg mL-1 (r =0.9996) for Naratriptan. The limit of detection was 0.5μg mL-1 and limit of quatitation was 1μg mL-1. The percentage recovery of Naratriptan was ranged from 97.2 to 99.5. The %R.S.D. values for intraday precision study were 1.0% and for inter-day study were 2.0%, confirming that the method was sufficiently precise. The validation studies were carried out fulfilling International Conference on Harmonisation (ICH) requirements. The procedure was found to be specific, linear, precise (including intra and inter day precision), accurate and robust.