METHOD DEVELOPMENT & VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF IMIPENEM AND RELEBACTUM IN BULK AND PHAMRACEUTICAL DOSAGE FORM BY UPLC

Pharmacy

A novel UPLC method was developed and validated for simultaneous estimation of Imipenem and Relebactam in bulk and pharmaceutical dosage form. Optimization is achieved by using the combination of methanol and water (70:30 v/v) in zodiac C18 column with a flow rate of 1.0ml/min at a wavelength of 270 nm. Imipenem and Relebactam were eluted at the retention time of 1.13 and 2.0 mins respectively. System suitability parameters were found to be within the limits. The method was shown to be specific, a s there is no interference of placebo peak with that of drug peak. The method to be linear in the concentration range of 50-150µg/ml for Imipenem and Relebactam With correlation coefficient 0.9991 and 0.9997 respectively. The method was found to be accurate as the percentage recovery was 99.2 and 100.4 for IPN &RLB and was within the limits. The percentage RSD was determined to be 0.08 and 0.07 for IPN & RLB, which indicates that the method was precise. The LOQ for this method was found to be 3.80µg/ml (IPN) and 3.88µg/ml (RLB) The LOD for this method was found to be 1.257µg/ml (IPN) and 1.26µg/ml (RLB). The developed UPLC method can be used for routine analysis of Imipenem and Relebactam in bulk and pharmaceutical.

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