Validated chromatographic methods for the simultaneous determination of a ternary mixture of sulfacetamide sodium and two of its official impurities; sulfanilamide and dapsone

Sulfacetamide sodium is a widely prescribed sulfonamide drug due to its topical antibacterial action on eye and skin. Four impurities are stated in the British Pharmacopoeia among which are sulfanilamide and dapsone. This work presents two specific, accurate and precise chromatographic methods for the simultaneous determination of a mixture of sulfacetamide sodium, sulfanilamide and dapsone. The first method is an isocratic RP-HPLC where the separation of components was achieved on C18 column. A green mobile phase was used consisting of methanol:water (60:40, v/v). The flow rate was 1.0 mL/min and effluent was monitored at 273 nm. The second method is a TLC-spectrodensitometric one where good separation was achieved by using silica plates and a mobile phase consisting of chloroform:dichloromethane:acetic acid (6:2.5:1.5, by volume). Determination was done by densitometry in the absorbance mode at 273 nm. Both methods were validated in compliance with ICH guidelines. They were also successfully applied for the determination of sulfacetamide sodium and its impurities in Ocusol® ophthalmic solutions. The obtained results were statistically compared to the results obtained by applying the official methods of analysis of each component where no significant difference was found with respect to accuracy and precision.

Preparation and Evaluation of Sulfacetamide Sodium Ocusert for Controlled Drug Delivery

The intent of this research was to formulate and evaluate controlled release ocusert of sulfacetamide sodium for the treatment of bacterial conjunctivitis. Ocusert is a sterile preparation having drug as dispersion or as solution in the polymeric base. Prepared Ocuserts were formulated using hydroxyl propyl methyl cellulose K-15 and Ethyl cellulose as polymers at various concentrations and combinations. Polymeric Films were prepared by mercury casting method using different ratios of polymers. Selected physiochemical properties such as thickness, weight, percentage moisture absorption, and in-vitro release and sterility studies of sulfacetamide sodium ocusert were studied and reported that prepared ocusert resolved the problems of poor bioavailability, frequent dosing and wastage of active ingredient. Keywords: Hydroxypropyl methyl cellulose K-15, ocusert, sulfacetamide sodium