Abstract: Background: Varenicline is suggested for use in smoking cessation and very few methods are reported for the determination of varenicline. Materials and Methods: A novel, simple, accurate, precise and stability indicating RP-HPLC method has been developed and validated for the assay of Varenicline in pharmaceutical formulations. Results: Separation was achieved within 10 min with required asymmetry, accuracy and precision thus enabling the utility of the method for routine analysis. Chromatographic separation was achieved on a Inertsil ODS 3 V 5 μm, 150x4.6 mm using a mobile phase consisting of 0.1% tri fluroaceticacid, methanol and Acetonitrile in the ratio of 8:1:1 at a flow rate of 1.0 mL per min. The detection was made at 235 nm. The retention time of Varenicline is 4.9 min. Conclusion: The method was validated and demonstrated good linearity, precision, accuracy and specificity in compliance with the regulatory requirements.
Key words: Varenicline, RP-HPLC, stability, formulations, validation