Spectroscopic strategies for quantitation of varenicline in pharmaceutical preparations and content uniformity testing

Abstract

Herein, two new facile methods were examined for varenicline determination using erythrosine. The latter is a food additive that has been recently investigated as a fluorescent dye for the determination of drugs. In the first method, the fluorescence of erythrosine B was quenched quantitatively by increasing the concentration of varenicline through ion-pair complex formation. This linear response was a basis for the spectrofluorimetric method used for varenicline quantitation in pure and dosage forms. The quenching is correlated with the concentration linearly over the range of 0.4–4.0 µg ml−1 at 550 nm after excitation at 528 nm with a correlation coefficient of 0.9993. Different parameters were investigated to reach the optimal conditions with the highest sensitivity and repeatability. The second method is depending on measuring the formed complex by spectrophotometry at 550 nm over the range of 1.0–10.0 µg ml−1 with an excellent correlation coefficient of 0.9999. The suggested methods were validated consistently with ICH guidelines, with acceptable results. The procedures were used to test the uniformity of content of Champix tablets. By comparing with the previous spectroscopic method, there was no significant difference as revealed from the calculated Student t-test and variance ratio F-test values.

Keywords

• erythrosine B
• varenicline
• fluorescence
• quenching
• spectrophotometry