Original Articles
A. S. Reddy, R. C. Reddy and P
Abstract
A sensitive and accurate high performance liquid chromatographic (HPLC) method was developed and validated to identify and characterize the unknown impurity found in zolmitriptan tablets during investigation of stability samples. The successful separation was achieved by using Inertsil ODS-3V, 150x4.6 mm, 5μm HPLC column with phosphate buffer (pH 3.0) as a mobile phase-A and methanol as mobile phase-B and detector wavelength at 225 nm. The gradient flow as delivered at a flow rate of 1.5 ml/min. The method was established by determining limit of detection and limit of quantification. The linearity and accuracy has been demonstrated at a range of LOQ to 400% and 50 to 200% of specification level respectively. The drug product was subjected to various stress conditions and proved the method stability indicating nature.