Sci. Pharm. 2012; 80: 115–126
Stress Degradation Studies on Varenicline Tartrate and Development of a Validated Stability-Indicating HPLC Method
Sudhakar S. PUJERI 1, Addagadde M. A. KHADER 1, Jaldappagari SEETHARAMAPPA * 2
1 Department of Chemistry, Mangalore University, Mangalagangotri, India.
2 Department of Chemistry, Karnatak University, Dharwad, India.
* Corresponding author. E-mail: jseetharam@yahoo.com (J. Seetharamappa)
Abstract
A simple, rapid and stability-indicating reversed-phase liquid chromatographic method was developed for the assay of varenicline tartrate (VRT) in the presence of its degradation products generated from forced decomposition studies. The HPLC separation was achieved on a C18 Inertsil column (250 mm x 4.6 mm i.d. particle size is 5 μm) employing a mobile phase consisting of ammonium acetate buffer containing trifluoroacetic acid (0.02M; pH 4) and acetonitrile in gradient program mode with a flow rate of 1.0 mL min−1. The UV detector was operated at 237 nm while column temperature was maintained at 40 °C. The developed method was validated as per ICH guidelines with respect to specificity, linearity, precision, accuracy, robustness and limit of quanti-fication. The method was found to be simple, specific, precise and accurate. Selectivity of the proposed method was validated by subjecting the stock solution of VRT to acidic, basic, photolysis, oxidative and thermal degradation. The calibration curve was found to be linear in the concentration range of 0.1–192 μg mL−1 (R2 = 0.9994). The peaks of degradation products did not interfere with that of pure VRT. The utility of the developed method was examined by analyzing the tablets containing VRT. The results of analysis were subjected to statistical analysis.
Keywords
Varenicline • Stability-indicating • Validation • Chromatographic assay • Chantix • Champix
Received September 25th, 2011 | Accepted December 5th, 2011 | Published Online December 5th, 2011
