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

Hashem Alaani,Yasmin Alnukkary

doi:10.15171/apb.2016.020

Hashem Alaani, Yasmin Alnukkary

Open Access

https://doi.org/10.15171/apb.2016.020

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Journal: Advanced pharmaceutical bulletin	Publication Date: Mar 17, 2016
Citations: 10	License type: cc-by

Affiliation: Damascus University

Abstract

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. 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. 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. The developed method is suitable for the routine analysis as well as stability studies.

Highlights

Chloramphenicol (CAP), Figure 1,A, is a bacteriostatic antibiotic.[1]
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
Dexamethasone Sodium Phosphate (DSP), Figure 1,B, is an inorganic ester of dexamethasone, that suppresses the inflammatory response to a variety of agents.[2]

Summary

Introduction

Chloramphenicol (CAP), Figure 1,A, is a bacteriostatic antibiotic.[1] Dexamethasone Sodium Phosphate (DSP),. 1,C, is an imidazoline-derivative sympathomimetic amine, which temporary relief of conjunctival congestion, itching, and minor irritation.[3] An ophthalmic solution contains CAP 0.5%, DSP 0.1%, and THC. It is indicated for keratitis, conjunctivitis acute and chronic infectious, inflammation of the uvea anterior, scleritis, and sympathetic ophthalmia..

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