European Journal of Chemistry

Development and validation of a stability-indicating RP-LC method for the simultaneous determination of otilonium bromide and its expected degradation product in bulk drug and pharmaceutical preparation

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Published: Mar 31, 2016
DOI: https://doi.org/10.5155/eurjchem.7.1.97-101.1358
Keywords:
RP-LC, Otilonium bromide, p-Aminobenzoic acid, Stability indicating assay, Pharmaceutical preparation, Simultaneous determination
Section
Research Article
Issue
Vol. 7 No. 1 (2016): March 2016
Dates
Received 2015-11-06
Accepted 2015-11-21
Published 2016-03-31


Main Article Content

Mohamed Mahmoud El-Kerdawy
Medicinal Chemistry Department, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt
Ramzia Ismail El-Bagary
Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt
Ehab Farouk Elkady
Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt
Ahmed Adel Othman
Central Administration for Pharmaceutical Affairs, Manyal, Cairo 11562, Egypt

Abstract

A simple, precise, accurate and rapid stability indicating liquid chromatography method had been developed for the simultaneous determination of otilonium bromide (OB) and its expected degradation product; p-aminobenzoic acid (PABA) in bulk powder and pharmaceutical preparation. Chromatographic separation was carried out by isocratic elution on Waters Atlantis C18 column (4.6 × 150 mm, 5 µm) using 2 mM ammonium acetate buffer (pH = 2.35) containing 0.05% TFA: acetonitrile (30:70, v:v) as the mobile phase. The flow rate was 0.8 mL/min with UV detection at 290 nm. Linearity was obtained over a concentration range of 0.5-100 μg/mL with regression coefficient of 1 for OB, and over concentration range of 1-50 μg/mL with regression coefficient of 0.9998 for PABA. The values of LOD and LOQ were found to be 0.0665 and 0.2018 μg/mL for OB and 0.1974 and 0.598 μg/mL for PABA, respectively. The method was validated as per ICH guidelines. The method was successfully applied to the determination of the drug in bulk powder and pharmaceutical preparation.


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El-Kerdawy, M. M.; El-Bagary, R. I.; Elkady, E. F.; Othman, A. A. Development and Validation of a Stability-Indicating RP-LC Method for the Simultaneous Determination of Otilonium Bromide and Its Expected Degradation Product in Bulk Drug and Pharmaceutical Preparation. Eur. J. Chem. 2016, 7, 97-101.

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