title: Novel liquid chromatographic methods for the determination of varenicline tartrate.
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-Ultra® C18 column (100 mm × 2.1 mm, 5 µm). 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 Symmetry® Waters C18 column (150 mm × 4.6 mm, 5 µm). Linearity, accuracy and precision were found to be acceptable over the concentration ranges of 0.5-20.0 µg mL(-1) and 0.2-20.0 µg mL(-1) 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.
authors.affiliation: Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt; Pharmaceutical Chemistry Deparment, Faculty of Pharmacy, Future University in Egypt.
authors.forename: Ramzia I
authors.initials: RI
authors.lastname: El-Bagary
authors.affiliation: National Organization for Drug Control and Research (NODCAR), P.O. Box 29, Giza 35521, Egypt.
authors.forename: Nisreen F
authors.initials: NF
authors.lastname: Abo-Talib
authors.affiliation: National Organization for Drug Control and Research (NODCAR), P.O. Box 29, Giza 35521, Egypt. Electronic address: marsmubarak@yahoo.com.
authors.forename: Marwa A El-Wahab
authors.initials: MA
authors.lastname: Mohamed
mesh_terms: D002853:Chromatography, Liquid / Q000295:instrumentation / Q000379:methods*; D004339:Drug Compounding; D055615:Electrical Equipment and Supplies; D006851:Hydrochloric Acid / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D057230:Limit of Detection; D016014:Linear Models; D013058:Mass Spectrometry; D010084:Oxidation-Reduction; D012997:Solvents / Q000737:chemistry; D013050:Spectrometry, Fluorescence; D013696:Temperature; D013997:Time Factors; D000068580:Varenicline / Q000032:analysis* / Q000737:chemistry
chemical_list: D012997:Solvents; D006851:Hydrochloric Acid; D000068580:Varenicline
keywords: Diode array detector; Fluorescence detector; NBD-Cl; Varenicline tartrate