A simple method is developed and validated for the simultaneous determination of imipenem (IMI) and Cilastatin (CIL) by RP-HPLC. Chromatographic separation of the drugs, achieved on Syncronis C-18 (250×4.6mm, 5µ) column at 245 nm using mobile phase, comprising a mixture of Methanol:Buffer (0.5% w/ v Potassium dihydrogen orthophosphate, pH adjusted to 6 with 1N NaOH) in the ratio of 50:50 v/v, at a flow rate of 1 ml/min. Cilastatin and Imipenem were eluted at the retention times of 2.51 min. and 4.10 min. respectively. Calibration curves were linear over the range of 10 µg – 1000 μg/ml and r2 values were 0.999 for both drugs. The % assay of imipenem and cilastatin were found to be 99.8% and 100.6% respectively. The performance of the method was validated according to ICH guidelines. The proposed method was successfully applied for the determination of Imipenem and cilastatin in injection formulation.
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