Development and validation of the HPLC method for varenicline determination in pharmaceutical preparation

Abstract

A simple and accurate reverse phase HPLC method has been developed and validated for quantification of varenicline in bulk drug and pharmaceutical dosage forms. Herein, an isocratic LC analysis was carried out on a Chromolith Performance RP18e column with methanol-buffer solution pH 3.5 (a buffer solution containing sodium benzoate (0.5 mmol/l) adjusted to pH 3.5 with trifluoroacetic acid (20 mmol/l) (55:45, V/V)) at a flow rate of 1.2 ml/min. The detection wavelength was set at 320 nm. The calibration curve was linear (r = 0.9999) in the studied range of concentration (0.2-10 μg/ml). The selectivity and sensitivity of the elaborated method were satisfactory, and the limits of detection and quantification was less than 20% of the specification level. Moreover, the inter- and intra-day precisions was found to be less than 3% (RSD), while the recovery values expressing inter- and intra-day accuracy was varied from 99.73 to 101.23. The varenicline solution was stable over a period of 3 days on storage under refrigeration. The utility of the developed method was examined by analysing the tablets containing VAR. As a result, the method was found to be selective, sensitive, precise and accurate.

Keywords

• varenicline
• development
• validation
• hplc