Development and Validation of RP-HPLC Method for Simultaneous Estimation of Meropenem and Sulbactam Sodium in Combined Dosage Form

Abstract

simple, precise and accurate reverse phase high performance liquid chromatographic (RPHPLC) method has been developed and validated for the simultaneous determination of Meropenem and Sulbactam Sodium from formulation. The chromatographic separation was performed on Hypersil C18 column (250 mm × 4.6 mm i.d, 5 μm particle size). Mobile phase consisted of a mixture of phosphate buffer (0.1 M KH2PO4, pH : 5), acetonitrile and methanol in the ratio of 90: 05: 05, v/v/v at a flow rate of 1.0 ml/min. The detection wavelength was set at 230 nm. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ. The calibration was linear over the range of 5-50 μg/ml for Meropenem and 5-50 μg/ml for Sulbactam Sodium. The retention times were 4.5 ± 0.004 min for Sulbactam sodium and 6.6 ± 0.008 min for Meropenem. The mean recoveries were 100.4 ± 0.61 and 98.5 ± 0.46 for Meropenem and Sulbactam sodium, respectively. The method can be easily adopted for quality control analysis.