ABSTRACT

The present work reports a validated reverse phase-HPLC method for determination of nortriptyline hydrochloride (NORH) in bulk and in its pharmaceutical dosage form. Chromatographic separation was performed on Waters C-18, (250×4.6mm, 5µm) stationary phase using a mixture of 50 mM KH2 PO4 pH 3.0 phosphate buffer: methanol: acetonitrile in the proportion of 50: 10: 40 V/V/V as mobile phase components at 1.0 mL min-1 flow rate. Detection of drug was carried out in isocratic mode at 235 nm. The validation of the method was carried out as per ICH guidelines. The LOD and LOQ for NORH was 0.22 µg mL-1 and 0.69 µg mL-1, respectively. NORH showed linearity range of 5-50 µg mL-1 and correlation coefficient (r2 ) value, 0.9937. The method was tested for assay of NORH in tablet dosage form.