Validated Chromatographic Methods for the Simultaneous Determination of Sulfacetamide Sodium and Prednisolone Acetate in their Ophthalmic Suspension.

Abstract

Two specific, sensitive, rapid and accurate chromatographic methods have been developed, optimized and validated for the simultaneous determination of sulfacetamide sodium and prednisolone acetate in pure forms and in their binary mixture. The first method is an isocratic Reversed phase-high performance liquid chromatography method where a rapid separation was achieved on a Zorbax ODS column using a green mobile phase of methanol: water (80:20, v/v) and pH adjusted to 5.0 ± 0.2 with orthophosphoric acid. The retention times (tR) were 2.21 and 3.64 min for sulfacetamide sodium and prednisolone acetate, respectively. The separated peaks were detected at 254 nm. The second method is a thin layer chromatography-densitometric method where the two drugs were separated on silica gel plates using a simple mobile phase of chloroform: methanol (90:10, v/v) and scanning of the separated bands was at 254 nm. The retardation factors (Rf) values were 0.37 and 0.64 for sulfacetamide sodium and prednisolone acetate, respectively. The suggested methods were validated in compliance with the ICH guidelines and were successfully applied to determine both drugs in their pure forms, laboratory prepared mixtures and dosage form. The obtained results were statistically compared to the official method where no significant difference was obtained with respect to both accuracy and precision.