Research Journal of Recent Sciences ________________________________________________ ISSN 2277 - 2502
Vol. 1(ISC-2011), 281-288 (2012)
Res.J.Recent.Sci.

Stability-Indicating LC Method for the Determination of Epinastine in Bulk
Drug and in Pharmaceutical Dosage Form
Ahirrao V.K. and Pawar R.P.
Department of Chemistry, Deogiri Science College, Aurangabad 431004, MS, INDIA

Available online at: www.isca.in
(Received 8th Decembert 2011, revised 10th January 2012, accepted 6th Fabruary 2012)

Abstract
A novel stability-indicating LC assay method was developed and validated for quantitative determination of epinastine in
bulk drugs and in pharmaceutical dosage form in the presence of degradation products generated from forced degradation
studies. An isocratic, reversed phase LC method was developed to separate the drug from the degradation products, using an
YMC ODS A- C18 (250 mm x 4.6 mm, 5 µm) column, and 0.05% v/v trifluroacetic acid and acetonitrile (65:35 v/v) as a
mobile phase. The detection was carried out at the wavelength of 220 nm. The epinastine was subjected to stress conditions
of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Degradation was observed for epinastine in base,
thermal and in 30% H2O2 conditions. The drug was found to be stable in the other stress conditions attempted. The
degradation products were well resolved from main peak. The percentage recovery of epinastine was ranged from (99.57%
to 100.25%). The developed method was validated with respect to the linearity, accuracy (recovery), precision, specificity
and robustness. The forced degradation studies prove the stability indicating power of the method.
Keywords: Column liquid chromatography, forced degradation, epinastine, stability indicating, method validation.

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