European Journal of Chemistry 2016, 7(1), 97-101 | doi: https://doi.org/10.5155/eurjchem.7.1.97-101.1358 | Get rights and content

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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


Mohamed Mahmoud El-Kerdawy (1) , Ramzia Ismail El-Bagary (2) , Ehab Farouk Elkady (3) , Ahmed Adel Othman (4,*)

(1) Medicinal Chemistry Department, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt
(2) Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt
(3) Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt
(4) Central Administration for Pharmaceutical Affairs, Manyal, Cairo 11562, Egypt
(*) Corresponding Author

Received: 06 Nov 2015 | Revised: 28 Nov 2015 | Accepted: 29 Nov 2015 | Published: 31 Mar 2016 | Issue Date: March 2016

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.


Keywords


RP-LC; Otilonium bromide; p-Aminobenzoic acid; Stability indicating assay; Pharmaceutical preparation; Simultaneous determination

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DOI: 10.5155/eurjchem.7.1.97-101.1358

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Funding information


Minapharm Co, Egypt

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How to cite


El-Kerdawy, M.; El-Bagary, R.; Elkady, E.; Othman, A. Eur. J. Chem. 2016, 7(1), 97-101. doi:10.5155/eurjchem.7.1.97-101.1358
El-Kerdawy, M.; El-Bagary, R.; Elkady, E.; Othman, 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(1), 97-101. doi:10.5155/eurjchem.7.1.97-101.1358
El-Kerdawy, M., El-Bagary, R., Elkady, E., & Othman, A. (2016). 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. European Journal of Chemistry, 7(1), 97-101. doi:10.5155/eurjchem.7.1.97-101.1358
El-Kerdawy, Mohamed, Ramzia Ismail El-Bagary, Ehab Farouk Elkady, & Ahmed Adel Othman. "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." European Journal of Chemistry [Online], 7.1 (2016): 97-101. Web. 12 Apr. 2021
El-Kerdawy, Mohamed, El-Bagary, Ramzia, Elkady, Ehab, AND Othman, Ahmed. "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" European Journal of Chemistry [Online], Volume 7 Number 1 (31 March 2016)

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