Adv Pharm Bull. 2016;6(1):137-141.
doi: 10.15171/apb.2016.020
PMID: 27123429
PMCID: PMC4845542
Scopus id: 84962420559
  Abstract View: 630
  PDF Download: 857

Short Communication

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

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.

Abstract

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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Submitted: 14 Jul 2015
Revised: 29 Jan 2016
Accepted: 04 Feb 2016
First published online: 17 Mar 2016
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