Analytical Method Development And Validation Of Spironolactone By Rp- Hplc Method

Abstract

A reversed-phase liquid chromatographic method has been developed and validated for estimation of Spironolactone in Pharmaceutical Dosage Form. RP-HPLC method, Column used was 150 x 4.6mm 5μ C18, Hypersil BDS with mobile phase containing 10mM Potassium dihydrogen Phosphate + 1% TEA (pH 4.5 Adjusted using Ortho phosphoric acid): Acetonitrile (50:50). The flow rate (1.0 ml/min) and wavelength (226 nm). The retention time of Spironolactone was found to be 4.509 min, respectively. Correlation co- efficient for Spironolactone was found to be 0.999. Assay result of marketed formulation was found to be in 99.7% for Spironolactone

Olamine. The proposed method was validated with respect to linearity, accuracy, precision and robustness. Percentage recovery for Spironolactone was found to be 99.7 – 100.0%. Analysis proves that the developed method was successfully applied for the analysis of pharmaceutical formulations and can be used for routine analysis of drugs in Quality Control laboratories