Topic > 55 - 861

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 product. In this study, the analyzes were carried out in a fused silica capillary (id 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 carried out in hydrodynamic mode for 7 seconds at a pressure of 50 mbar. The capillary temperature was set to 35 °C and the detection was performed with a wavelength of 205 nm. The background electrolyte was 40 mM citrate buffer at pH 6.0, and the internal standard was labetalol HCl. The total analysis time was less than 5 minutes. The method was validated according to ICH guidelines and was found to be linear, precise, accurate, specific, robust and robust. The linearity range was found to be 1.0 – 60.0 µg mL-1 and the limit of detection and quantification was found to be 0.5 and 1.0 µg mL-1, respectively. The method was successfully applied for the determination of varenicline tartrate in its pharmaceutical dosage forms. In short; An environmentally friendly, economical and rapid process using capillary electrophoresis has been described. The sample preparation and analytical application procedure does not use organic solvents and the total analysis time is less than 5 minutes. Therefore, the developed zonal capillary electrophoresis method for the 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 in conjunction with training and counseling… half of the article… in the literature, VT has been analyzed by HPLC [9-14], UV spectrophotometry [15], and electrochemistry [16]. Although a CE method is also reported in the literature [17], the CE method developed in this study is different from the one reported as the internal standard and the BGE used for the developed method are totally different. A comprehensive method optimization process was applied for the proposed method and a wider linearity range (1.0 – 60.0 µg mL-1) was obtained than reported (1.0 – 16.0 µg mL-1). The method developed in this study has been fully validated, including robustness and robustness. Therefore, it is now certain that minor modifications do not affect the reproducibility of the developed method and in this way it constitutes a notable and important alternative to the reported CE method and other methods for quality control of VT in the pharmaceutical industry.