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2016-03-31T05:10:15Z
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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
El-Kerdawy, Mohamed Mahmoud
El-Bagary, Ramzia Ismail
Elkady, Ehab Farouk
Othman, Ahmed Adel
RP-LC
Otilonium bromide
p-Aminobenzoic acid
Stability indicating assay
Pharmaceutical preparation
Simultaneous determination
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.
Atlanta Publishing House LLC
2016-03-31
info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
application/pdf
https://www.eurjchem.com/index.php/eurjchem/article/view/1358
10.5155/eurjchem.7.1.97-101.1358
European Journal of Chemistry; Vol. 7 No. 1 (2016): March 2016; 97-101
2153-2257
2153-2249
eng
https://www.eurjchem.com/index.php/eurjchem/article/view/1358/pdf_1358