The Development and Validation of Stability Indicating Analytical Method for Determination of Nortriptyline in Nortriptyline HCl Tablets by Liquid Chromatography

Purpose: To develop and validate a rapid, rugged, precise and an accurate stability indicating analytical method for determination of Nortriptyline HCl in Nortriptyline tablets. The separation of impurities and Nortriptyline HCl drug was achieved by an isocratic liquid chromatographic method using Inertsil, C18, 250 mm x 4.6 mm, 5μm column at 45ºC. The mobile phase consists of 70% Methanol and 30% phosphate buffer of pH-7.5 pumped at a flow rate of 1.0 ml/min. The detection was carried out at a wavelength 220 nm. The proposed chromatographic method was validated and found to be linear over the concentration range of 50 - 150.0 μg/ml. Mean recovery of Nortriptyline HCl was found to be 100.1±0.1%w/w. Conclusion: The method was found to be simple, stability indicating, precise, accurate and robust which can be utilized for the determination of assay of Nortriptyline HCl in Nortriptyline tablets.