Hashem AlAani
1*, Yasmin Alnukkary
21 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.