HPLC Determination of Sulphacetamide Sodium & Prednisolone Acetate: A Routine Quality Control Pharmaceutical Analysis

In this research work a rapid reversed phase liquid chromatographic method was developed and validated for Sulphacetamide Sodium (SCS) and Prednisolone Acetate (PAC) in ophthalmic suspension. Chromatographic separation was achieved by using ammonium acetate buffer and methanol (0.02M; pH 4.0) (30:70 V/V) at a flow rate of 1.5 ml/min. The effluent from column was monitored by means of Diode array detector at 271 nm and 245 nm for SCS & PAC. The retention time for SCS was 1.8 and for PAC was 3.6. A good linear relationship was observed over the concentration ranges 0.016-10 ?g/ml and 0.64-400 ?g/ml with correlation coefficient 0.9999 and 0.9999 for SCS and PAC respectively. Calculated LOD & LOQ were 15 ng/ml and 18 ng/ml and 46 ng/ml and 55 ng/ml for SCS and PAC respectively. All the excipients and degradation products were resolved in > 6 mints with R < 1.5. The developed method was validated according to ICH guidelines.