2026-04-21T09:46:20Z https://www.eurjchem.com/index.php/eurjchem/oai

oai:ojs.www.eurjchem.com:article/1358 2016-03-31T05:10:15Z eurjchem:ART driver

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