Development and Validation of RP-HPLC Method for Assay of Seratrodast in Pharmaceutical Dosage Form

The present work describes a simple reverse-phase high performance liquid chromatographic method for estimation of the drug Seratrodast in pure and in tablet dosage form. The estimation was carried out on a Thermo Hypersil C 18 (150mm × 4.6 mm i.d., particle size 5μm) column with a mixture of Phosphate buffer, Acetonitrile and Water with a pH 6.8 adjusted with ortho phosphoric acid in the ratio of 50:40:10%v/v. UV detection was performed at 266nm. The retention time was 6.016 min. and the flow rate was 1.0 ml min⁻¹. The calibration curve was linear over the concentration range of 200-600ppm. The LOD and LOQ values were found to be 2.5 and 9.6. The method was validated for accuracy, specificity, limit of quantification, limit of detection, robustness and stability. The results showed that proposed method is successfully applied for the quantitative estimation of Seratrodast in pharmaceutical dosage form.