The present study aimed to develop and validate two simple, rapid, and reliable UV spectroscopic methods for the simultaneous estimation of Varenicline Tartrate in bulk drug samples, following the guidelines of the International Council for Harmonisation (ICH). Method A is based on the absorption maxima (λ_max) approach, where the absorbance of Varenicline Tartrate is measured at 237.60 nm. This method allows for direct quantification and provides high sensitivity for the analyte. Method B employs the Area Under Curve (AUC) technique, which involves measuring the integrated absorbance over the wavelength range of 230.40–243.00 nm. The AUC method offers improved precision by accounting for slight spectral variations and reducing potential errors associated with single-point measurements.
Both methods were evaluated for their linearity, accuracy, and precision, and were found to be linear over a concentration range of 2–10 µg/mL for Varenicline Tartrate. The results indicate that these UV spectroscopic techniques are suitable for routine quality control analysis of bulk Varenicline Tartrate, providing simple, cost-effective, and reproducible approaches for its estimation in pharmaceutical laboratories. The methods can be further applied for the analysis of formulations after appropriate validation.