Abstract

STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF IMIPENEM AND CILASTATIN IN INJECTION FORMULATIONS

Murali D.* and Purnachandra Rao G.

Abstract

Reverse Phase High Performance Liquid Chromatographic forced degradation method have been developed and validated for the simultaneous estimation of Imipenem (IPM) and Cilastatin (CSN) in Injection formulations. Both drugs and their degradation studies were conducted by using Inertsil- C18, BDS (250 mm x 4.6;5μm particle size) column and the separation was achieved by using methanol : acetonitrile (80:20) as mobile phase and flow rate was 1.0ml/min with runtime 8mins at ambient temperature, and the retention time for both drugs was 2.930 mins for IPM and 4.215 for CSN respectively. This method was linear at the concentration range of 20-80μg/ml (R2=0.9990 & R2=0.9991) for both IPM and CSN respectively. The stability indicating studies of the method was developed by subjecting both drugs to various stress conditions like acid, base, oxidation, heat and photo light. There were no interfering peaks from excipients or degradation products have developed due to variable degradation conditions. Degradation products produced as a result of forced degradation studies did not interfere with the detection of Imipenem and Cilastatin and the method can thus be considered stability indicating.

Keywords: Imipenem, Cilastatin, Stability indicating, Injection, RP-HPLC, Simultaneous, Forced degradation.