A New Simple Analytical Development and Validation of Imipenem and Cilastatin by Simultaneous Estimation of Pharmaceutical Dosage Form by RP-HPLC

Author(s): Santhosh Illendula*, Gutha Pravllika and Paladugu Ashok Reddy

Abstract: A simple, rapid, precise, accurate and sensitive reverse phase liquid chromatographic method has been developed for the determination of imipenem and cilastatin by simultaneous estimation of pharmaceutical dosage form. The chromatographic method was standardized using X-Terra C18, 4.6×250mm 5.0μm i.d. column with UV detection at 238nm and mobile phase with the composition of phosphate buffer Ph 3.0: Acetonitrile with (50:50) ratio at a flow rate of 1.0 ml/min. The proposed method was successfully applied to the determination of imipenem and cilastatin by simultaneous estimation of pharmaceutical dosage form. The method was linear and accurate in the range of 50ppm-250ppm of Imipenem and Cilastatin. The recovery was in the range of 98% to 102% and limit of detection of Imipenem and Cilastatin was found to be 2.17μg/ml and 0.037μg/ml and quantification was found to be 6.60 μg/ml and 0.112μg/ml. Different analytical performance parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to International Conference on Harmonization (ICH) guidelines.

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