METHOD DEVELOPMENT AND VALIDATION OF ZOPICLONE IN BULK AND TABLET DOSAGE FORM USING RP-HPLC
AbstractZopiclone belongs to a class of medicines commonly called Z-drugs. It is a novel hypnotic agent used in the treatment of insomnia. Its mechanism of action is based on modulating benzodiazepine receptors. A Reverse Phase High Performance Liquid Chromatography method was developed and validated for the quantification of zopiclone in bulk and tablet dosage form. Chromatography was achieved using a Waters X Bridge C18 column (50 x 2.1 mm, 5μ) eluted with a mixture of mobile phase composed of ammonium bicarbonate (5mM, neutral) and acetonitrile in a gradient mode at a flow rate of 1 ml/min. The detection of eluent from the column was detected using photo diode array detector (PDA) at 214nm. The stability indicating assay method was developed and validated as per the ICH guidelines using the required parameters. Linearity was observed within the concentration range of 50-300μg/ml with coefficient of correlation 0.999. The LOD and LOQ were 9.416μg/ml and 28.534μg/ml, respectively. The mean recovery was found to be 100.1%.
Article Information
26
2876-81
449
1702
English
Ijpsr
I. Chopra *, J. Kaur, D. K. Yadav, M. Hasan, P. K. Tyagi and B. Kumar
College of Pharmacy, Shree Ganpati Institute of Technology, Ghaziabad -201302, Uttar Pradesh, India
isha0220@gmail.com
12 November, 2014
12 January, 2015
18 March, 2015
10.13040/IJPSR.0975-8232.6(7).2876-81
01 July, 2015