Development and validation of the UV spectroscopic method for varenicline determination in pharmaceutical preparation

Abstract

A simple and accurate UV visible spectroscopic method has been developed and validated for quantification of varenicline in bulk drug and pharmaceutical dosage forms. A shimadzu UV spectrophotometer was used considering availability and cost effectiveness of the proposed method. λmax of 236nm and 319nm were observed from the spectroscopic method. The calibration curve was linear (r = 0.99) in the studied range of concentration (5- 40 µg /ml) in both the absorption maxima. The selectivity and sensitivity of the elaborated method were satisfactory, and the limits of detection and quantification were less than 20% of the specification level. Moreover, the inter- and intra-day precisions was found to be less than 3% (RSD), while the recovery values expressing inter- and intra-day accuracy was varied from 99.73 to 101.23. The varenicline solution was stable over a period of 3 days on storage under refrigeration. The utility of the developed method was examined by analyzing the tablets containing VAR. As a result, the method was found to be selective, sensitive, precise and accurate.