National Organization of Drug Research and Control NODCAR

Al Jīzah, Egypt

National Organization of Drug Research and Control NODCAR

Al Jīzah, Egypt
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El-Bagary R.I.,Cairo University | Boshra A.,National Organization of Drug Research and Control NODCAR | El-Hakeem M.M.,Cairo University | Abdelra'oof A.M.,National Organization of Drug Research and Control NODCAR
Journal of Chemical and Pharmaceutical Research | Year: 2012

Three simple and sensitive methods, namely, difference spectrophotometric, colorimetric and HPLC methods are described for the determination of epinastine hydrochloride (EPH) in pure form and ophthalmic solution. First, the drug is determined quantitatively by pH-induced difference spectrophotometry. The method is based on the measurement of the difference absorbance at 252nm of epinastine hydrochloride (EPH) in 0.1N NaOH against equivalent amount in 0.1N HCl as a blank. Beer's law was obeyed for the studied drug over the range of 16 to 96 μg.ml -1. In the second method, the drug is converted to its corresponding free base which is treated with chloranilic acid (CAA) solution in acetonitrile to give a colored product with an absorption maximum at 517 nm. Various experimental parameters and the stoichiometry of the reaction were investigated and optimized. Linearity is obeyed over the range of 20-220 μg.ml -1. The third is an HPLC method, which is developed for the determination of EPH using acetonitrile: 0.1 M ammonium acetate buffer (40:60 v/v) as a mobile phase at a flow rate 1 ml/min and UV detection at 262nm. Methyl paraben was used as internal standard. The linearity range was from 20 to 100 μg.ml -1. The proposed methods were validated according to the guidelines of the ICH and were also statistically compared with the reference method showing no significant difference concerning accuracy and precision.

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