Development and validation of RP-HPLC method for simultaneous quantification of sulfacetamide sodium and prednisolone sodium phosphate

Abstract

Sulfacetamide sodium (SFS), in combination with prednisolone sodium phosphate (PSP), is indicated for ophthalmic infections. The present study describes a reverse phase-high performance liquid chromatography method for simultaneous estimation of these two drugs using a diode-array detector. Isocratic elution with solvent system acetate buffer (0.01 M, pH 7): acetonitrile: methanol 75: 20: 5 (v/v/v), at a flow rate of 0.8 mL/min gave the optimum resolution. The detection limits for SFS and PSP were calculated as 1.15 µg/mL and 1.45 µg/mL, while quantification limits were 3.83 µg/mL and 4.84 µg/mL respectively. Accuracy was found to be 99-101% with relative standard deviation (RSD) values less than 2%. The proposed method is accurate, precise, sensitive, reproducible and applicable for normal usage in quality control laboratories. It would prove advantageous in utilizing less time and resources as previously there is no reported single assay for simultaneous quantification of the aforementioned drugs.