A NEW SIMPLE AND SENSITIVE RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF NORTRIPTYLINE AND PREGABALIN IN BULK AND TABLET DOSAGE FORM

A rapid, precise, accurate, specific and simple RP-HPLC method was developed for the simultaneous estimation of Nortriptyline and Pregabalin in bulk and its combined pharmaceutical dosage form. A High performance liquidchromatograph WATERS, software: Empower 2, 2695 separation module, 996 PDA detector, using Phenomenex Luna C18 (4.6mm×250mm) 5 µm or equivalent column, with mobile phase composition of Methanol: Phosphate Buffer pH-3.0 (70:30v/v) was used. The flow rate of 1.0 ml min-1 and effluent was detected at 230 nm. The retention time of Nortriptyline and Pregabalin was found to be 1.870min and 2.499minutes respectively.Linearity was observed over concentration range of 10-50µg ml-1 for Nortriptyline and 16-80µg ml-1 for Pregabalin respectively. The accuracy of the proposed method was determined by recovery studies and the Nortriptyline was found to be 99.1% and Pregabalin was found to be 98.8% respectively. The proposed method isapplicable to routine analysis of Nortriptyline and Pregabalin in bulk and pharmaceutical formulations. The proposed method was validated for various ICHparameters like linearity, limit of detection, limits of quantification, accuracy, precision, range and specificity.

Key Words: Nortriptyline, Pregabalin, RP-HPLC, Robustness and ICH Guidelines.