Evaluation of a capillary electrophoresis method for routine determination of varenicline tartrate in quality control laboratories

Abstract

<p class="Body"><span lang="EN-US">In this study, analyses were carried out in a fused-silica capillary (i.d. 50.0 µm, total length 48.5 cm and effective length 40.0 cm), in normal mode, applying a voltage of 20 kV. Sample injections were made in a hydrodynamic mode over 7 seconds under a pressure of 50 mbar. Capillary temperature was set at 35 ^°C and the detection was performed at 205 nm wavelenght. Background electrolyte was </span><span lang="EN-US">40 mM citrate buffer at pH 6.0 and the internal standard was labetalol HCl. Total analysis time was shorter than 5 minutes. The method was validated according to the ICH guidelines and it was found to be linear, precise, accurate, specific, robust and rugged. Linearity range was found to be </span><span lang="EN-US">1.0 – 60.0 µg mL^-1 and the limit of detection and quantitation were found as 0.5 and 1.0 µg mL^-1, respectively. </span></p><p class="Body"><span lang="EN-US"> </span></p>