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The Thai Journal of Pharmaceutical Sciences

Abstract

A high performance thin layer chromatography (HPTLC) method was developed and validated for the simultaneous quantification of dexamethasone sodium phosphate and chloramphenicol in eye drop. The HPTLC separation was achieved on an aluminum-backed layer of silica gel 60F254 using acetonitrile: water: ammonia (10:3:0.5 v/v/v), pH adjusted to 7.8 with 1M HCl, as a mobile phase. The densitometric determination of dexamethasone phosphate and chloramphenicol was carried out at 262 nm. Calibration curves for dexamethasone phosphate and chloramphenicol were linear in the range of 80-300 ng and 400-1400 ng, respectively. The method was validated according to International Conference on Harmonization (ICH) guidelines for selectivity, recoveries, and intra-day and inter-day variation. The developed method was applied for the simultaneous determination of dexamethasone phosphate and chloramphenicol in eye drop. Results obtained indicated that the method is simple, specific, selective and reliable for simultaneous quantitative determination of dexamethasone phosphate and chloramphenicol in pharmaceutical formulations. The developed HPTLC method can be applied for differentiation of the degradation products from the intact drugs. Since the method can separate the drugs from their degradation products, it can be employed as a stability indicating one.

DOI

10.56808/3027-7922.3318

First Page

94

Last Page

107

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