A validated stability-indicating HPLC method for determination of varenicline in its bulk and tablets

Abstract

A simple, sensitive and accurate stability-indicating HPLC method has been developed and validated for determination of varenicline (VRC) in its bulk form and pharmaceutical tablets. Chromatographic separation was achieved on a Zorbax Eclipse XDB-C8 column (150 mm × 4.6 mm i.d., particle size 5 μm, maintained at ambient temperature) by a mobile phase consisted of acetonitrile and 50 mM potassium dihydrogen phosphate buffer (10:90, v/v) with apparent pH of 3.5 ± 0.1 and a flow rate of 1.0 ml/min. The detection wavelength was set at 235 nm. VRC was subjected to different accelerated stress conditions. The degradation products, when any, were well resolved from the pure drug with significantly different retention time values. The method was linear (r = 0.9998) at a concentration range of 2 - 14 μg/ml. The limit of detection and limit of quantitation were 0.38 and 1.11 μg/ml, respectively. The intra- and inter-assay precisions were satisfactory; the relative standard deviations did not exceed 2%. The accuracy of the method was proved; the mean recovery of VRC was 100.10 ± 1.08%. The proposed method has high throughput as the analysis involved short run-time (~ 6 min). The method met the ICH/FDA regulatory requirements. The proposed method was successfully applied for the determination of VRC in bulk and tablets with acceptable accuracy and precisions; the label claim percentages were 99.65 ± 0.32%. The results demonstrated that the method would have a great value when applied in quality control and stability studies for VRC.

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

“…Thus, the proposed CE method might be evaluated as a good and "green" alternative for the routine determination of VT compared to other automated analytical techniques such as high-performance liquid chromatography (HPLC). VT has been analyzed by HPLC [5][6][7][8][9][10], ultraviolet (UV) spectrophotometry [11], and electrochemistry [12]. Although, a new CE method [13] has recently been reported for the determination of VT in pharmaceutical dosage forms, the developed method presented herein differs from the previously reported one by the type of internal standard and BGE used.…”

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

“…Although the light absorption characteristics of VAR are available in literature [9,12], we recorded the UV-absorption spectrum in methanol in order to select the appropriate analytical wavelength, while simultaneously verifying available data. As shown in Figure 1, VAR has three absorption maxima at 237, 269 and 320 nm which were considered in further analysis.…”

“…Available clinical-trial data support its use as an effective and generally well-tolerated therapy for smoking cessation in healthy adult smokers [6]. High performance liquid chromatography (HPLC) is the predominant method used for varenicline analysis [7][8][9][10][11][12][13][14]. Other analytical techniques are used sporadically, including mainly spectroscopic techniques [10,15,16].…”

“…Most frequently, papers refer to the quantification of varenicline in its pharmaceutical preparations [7][8][9][10][11][12]15,16]. Quality control of varenicline-containing preparations using a simple, sensitive, precise and accurate HPLC methods is necessary due to the fact that these preparations are often imported and are often exposed to different transport conditions [9].…”

“…Varenicline has been analyzed using UV-VIS spectrophotometry [15], fluorimetry [16], nuclear magnetic resonance spectroscopy (1H NMR and 13C NMR) [10], mass spectrometry (MS) [10,13,14] and Fourier-transform infrared spectroscopy (FTIR) [10]. Most frequently, papers refer to the quantification of varenicline in its pharmaceutical preparations [7][8][9][10][11][12]15,16]. Quality control of varenicline-containing preparations using a simple, sensitive, precise and accurate HPLC methods is necessary due to the fact that these preparations are often imported and are often exposed to different transport conditions [9].…”