55

Quality control is a routine application for the pharmaceutical industry. It refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical. 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 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 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. The method was successfully applied for determination of varenicline tartrate in its pharmaceutical dosage forms. In conclusion; a green, cheap and rapid process was described by using capillary electrophoresis. The sample preparation and analytical application procedure do not use any organic solvent and the total analysis time is shorter than 5 minutes. Thus, the developed capillary zone electrophoresis method for determination of varenicline tartrate in its pharmaceutical dosage forms is particularly suggested for routine applications in quality control laboratories.

Keywords: Capillary electrophoresis, varenicline tartrate, analytical method validation, pharmaceutical dosage forms, quality control

Varenicline is used along with education and counseling ...

... middle of paper ...

...n the literature, VT was analyzed by HPLC [9-14], UV Spectrophotometry [15] and electrochemistry [16]. Although, there is also reported a CE method [17] in the literature, the developed CE method in this study is different than the reported one as a result of the internal standard and BGE used for the developed method are totally different. A comprehensive method optimization process was applied for the proposed method and achieved a wider linearity range (1.0 – 60.0 µg mL-1) than the reported one (1.0 – 16.0 µg mL-1). The developed method in this study was fully validated including robustness and ruggedness. Thus, now it is certain that minor changes do not affect the reproducibility of the developed method and by that way it is a notable and important alternative to the reported CE method and other methods for the quality control of VT in pharmaceutical industry.