Validated Stability Indicating HPLC Method for Estimation of Naratriptan

Abstract

This work states validated stability indicating HPLC method for estimation of naratriptan hydrochloride. Chromatographic Analysis was performed using LC-GC Qualisil Gold, C18 (250 X 4.6 mm i.d., 5 μ). Isocratic mode of separation was followed. The linearity range of Naratriptan Hydrochloride was 3-18 µg/ml. The value of correlation coefficient was 0.9990. The % RSD values in the Precision studies were < 2%. This confirmed that the method was sufficiently precise. The accuracy of the method was validated by recovery studies and was found to significant and under specification limits, with % recovery 98.56-101.03. The assay result was found to be 100.68%. The method also passes the specifications for robustness parameters. Limit of detection of naratriptan hydrochloride was found to be 0.0173 µg/ml and Limit of quantification of naratriptan hydrochloride was found to be 0.0572 µg/ml and also other ICH guidelines are validated.