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


CONCLUSIONS
The developed method is suitable for the routine analysis as well as stability studies.
Department of Chemistry, Faculty of Science, Damascus University, Damascus, Syria.
Hashem
H
AlAani
Department of Pharmaceutical Chemistry and Drug Quality Control, Faculty of Pharmacy, Damascus University, Damascus, Syria.
Yasmin
Y
Alnukkary
Chloramphenicol; Dexamethasone Sodium Phosphate; HPLC; Ophthalmic Solution; Stability-indicating; Tetrahydrozoline Hydrochloride