Author : Ramzia Ibrahim
CoAuthors : Nisreen F. Abo- Talib , Marwa A. El- Wahab
Source : Talanta
Date of Publication : 01/2016
Abstract : Two simple, sensitive, rapid, and stability-indicating liquid chromatographic (LC) methods have been
developed for the determination of varenicline tartrate. They comprised the determination of varenicline
(VRC) in the presence of its oxidative degradates and related impurity (N-formyl varenicline) (NFV). The
first method was a LC with diode array detection (DAD) at 235 nm using Ristek-Ultras C18 column
(100 mm 2.1 mm, 5 mm). Isocratic elution of VRC was employed using a mobile phase consisting of
buffer mixture (1.2% potassium dihydrogen phosphate and 0.08% octane sulphonic acid): acetonitrile
(86:14, v/v), pH (5.0). In the second method; a fluorimetric detection technique was developed, based on
precolumn derivatization of VRC using 7-chloro-4-nitrobenzo-2-oxa-1, 3-diazole (NBD-Cl). The fluorescence
detector (FLD) was operated at 474 nm for excitation and 539 nm for emission. Isocratic elution
was applied with a mobile phase consisting of methanol-distilled water (70:30, v/v). Separation was
achieved using Symmetrys Waters C18 column (150 mm 4.6 mm, 5 mm). Linearity, accuracy and precision
were found to be acceptable over the concentration ranges of 0.5–20.0 mg mL1 and 0.2–
20.0 mg mL1 with the first and the second method, respectively. The optimized methods were validated
and proved to be specific, simple, and accurate for the quality control of the drug in its pharmaceutical
preparation.
& 2015
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