Development and Validation of Stability Indicating HPLC Method For Determination of Varenicline Tartrate And Its Related Substances In Tablet Dosage Form

Abstract

Varenicline tartrate is a prescribed medication used for smoking cessation. Varenicline is nicotine receptor partial agonist. The aim of research work was to establish simple, specific, accurate and precise stability indicating reverse phase HPLC method. A HPLC method was developed and validated for determination of varenicline tartrate and its related substances in tablet dosage forms as per ICH guidelines. Chromatographic separation of varenicline tartrate was achieved on Thermo Acclaim 120 Å C18, (250mm x 4.6mm, 5μm) column using gradient mobile phase system consisting of buffer solution: Methanol (95:05) at 1mL/min flow rate. Varenicline detection was done at 237nm using photo diode array detector. Specificity was evaluated by subjecting sample to acidic, basic, oxidation, thermal and photolytic stress degradation conditions. Peaks of drug substance and related substances (Dioxo impurity and N-formyl impurity) resolved from each other with no interference from excipients. Stability indicating RP-HPLC method of analysis for varenicline tartrate was accurate, precise and robust with good recovery (>95%) and %RSD for all parameters was found to be not more than 2.0%. A linear relationship was observed for method calibration curve in range of 0.1-1.5μg/mL (varenicline), 0.2-3μg/mL (related substances) with r2 value >0.999. This method can also be capable for detecting and quantifying known impurities and degradant of drug substance. Further, this method can be applied for determination of varenicline and its RS in tablet dosage forms.