Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF IMIPENEM AND CILASTATIN SODIUM POWDER FOR INJECTION BY RP-HPLC

Dr. Ch. Saibabu*, M. Praveen Kumar, Dr. M. Bhaskar

Abstract

A reserve phase liquid chromatography (RP-HPLC) method has been developed and subsequently validated for the determination of Imipenem and Cilastatin sodium bulk and its pharmaceutical formulation. Separation was achieved with a Inertsil ODS SP C18,( particles with 5µm), 250mm x 4.6mm column and Sodium 1-hexane sulfonate and potassium dihydrogen orthophosphate buffer pH 6.8 as mobile phase at a flow rate of 2.5 ml/min and the column temperature was maintained at 50˚c.Dual wavelength detector was performed at 254 nm and sample temperature was maintained at 5˚c with a run time of 20 minute. The method rapid simple and sensitive. The described method of Imipenem and Cilastatin is linear over a range of 60µg/ml and 120µg/ml with correlation coefficient of 0.998, 0.998 respectively for both Imipenem and Cilastatin. The method precision for determination of assay was below 2.0% RSD. The method enables accurate, precise and rapid analysis of Imipenem and Cilastatin. It can be conveniently adopted for routine quality control analysis of bulk and pharmaceutical formulations.

Keywords: Imipenem and Cilastatin, HPLC, Assay, Method development.