METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF OFLOXACCIN AND SATRANIDAZOLE BY USING RP-HPLC

Abstract

A new simple, accurate, rapid and precise gradient High Performance Liquid Chromatographic (HPLC) method was developed and validated for simultaneous estimation of Ofloxaccin and satranidazole in combined dosage form. The method employs waters HPLC system on Hypersil BDS C18 Column (250 mm X 4.6 mm, 5 µ), with a flow rate of 1.0 ml / min with a load of 10 µl. Water + OPA (Ortho Phosphoric Acid) having pH 5.0 and acetonitrile was used as a mobile phase in the composition of 60:40 % v/v. The detection was carried out by PDA detector at 295 nm. Linearity ranges for Ofloxaccin and satranidazole were 100 – 300 mg / ml for Ofloxaccin, 150 – 450 mg / ml for satranidazole respectively. Retention time of Ofloxaccin and Satranidazole were found to be 2.881 minutes, 4.042 minutes respectively. Percent recovery study values of Ofloxaccin and Satranidazole were found to be 99.003 – 100.5 % and 98.6 – 100.4 % respectively. This newly developed method was successfully utilized for the quantitative estimation of Ofloxaccin and Satranidazole in combined pharmaceutical dosage forms. This method was validated as per ICH guidelines.