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Advanced Pharmaceutical Bulletin
ISSN: 2228-5881      eISSN: 2251-7308  
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Article History
Submitted: 14 Jul 2015
Revised: 29 Jan 2016
Accepted: 04 Feb 2016
First published online: 17 Mar 2016

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Adv Pharm Bull. 2016;6(1):137-141 doi: 10.15171/apb.2016.020
PMID:27123429        PMCID:PMC4845542

Stability-Indicating HPLC Method for Simultaneous Determination of Chloramphenicol, Dexamethasone Sodium Phosphate and Tetrahydrozoline Hydrochloride in Ophthalmic Solution

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Hashem AlAani 1 * , Yasmin Alnukkary 2

1 Department of Chemistry, Faculty of Science, Damascus University, Damascus, Syria.
2 Department of Pharmaceutical Chemistry and Drug Quality Control, Faculty of Pharmacy, Damascus University, Damascus, Syria.

Purpose: A simple stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of Chloramphenicol, Dexamethasone Sodium Phosphate and Tetrahydrozoline Hydrochloride in ophthalmic solution in the presence of 2-amino-1-(4-nitrophenyl)propane-1,3-diol, a degradation product of Chloramphenicol, and Dexamethasone, a degradation product of Dexamethasone Sodium Phosphate. Methods: Effective chromatographic separation was achieved using C18 column (250 mm, 4.6 mm i.d., 5 μm) with isocratic mobile phase consisting of acetonitrile - phosphate buffer (pH 4.0; 0.05 M) (30:70, v/v) at a flow rate of 1 mL/minute. The column temperature was maintained at 40°C and the detection wavelength was 230 nm. Results: The proposed HPLC procedure was statistically validated according to the ICH guideline, and was proved to be stability-indicating by resolution of the APIs from their forced degradation products. Conclusion: The developed method is suitable for the routine analysis as well as stability studies.

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