Stability indicating method development and validation for the simultaneous estimaion of fluorometholone and sulfacetamide sodium in bulk and pharmaceutical dosage forms by RP-HPLC

Abstract

An accurate, simple, reproducible and sensitive method for the simultaneous determination of Fluorometholone and Sulfacetamide sodium was developed and validated as per ICH Guidelines. Fluorometholone and Sulfacetamide sodium were separated by HPLC using a Shimadzu RP-18 column (5µm,250mm×4.6mm i.d) and isocratic elution with a flow rate of 1 mL/min. Mixture of Acetonitrile and 1% Ortho Phosphoric (pH=5.0) (70:30) was used as mobile phase. The detection was at 254 nm wavelength. The retention time of FLUO and SULF was found to be 3.614 and   2.578 min respectively. The linearity of developed method was achieved in the range of 10-50 µg/mL (r² = 0.998) and 5-25µg/mL (r² = 0.998) for Fluorometholone and Sulfacetamide sodium respectively. LOD of both the drugs were 0.0510µg/mL and 0.0031µg/mL and LOQ was found to be 0.1547µg/mL and 0.0095µg/mL for Fluorometholone and Sulfacetamide sodium respectively. Recovery and assay studies of Fluorometholone and Sulfacetamide sodium were within 99% to 102% indicating that the proposed method is suitable for routine analysis of ophthalmic formulation.