Abstract

A NOVAL METHOD DEVELOPMENT AND VALIDATION OF IMIPENEM IN BULK AND INJECTION FORMULATIONS BY SPECTROPHOTOMETRIC AND RP-HPLC METHODS

Dr. K. Raghu Babu, N. Aruna Kumari*, Dr.A.Vasundhara

ABSTRACT

A simple and cost effective spectrophotometric method was described for the determination of Imipenem in pure form and in pharmaceutical formulations. The method is based on the formation of pink colored chromogen when the drug reacts with N-Bromo Succinamide(NBS) reagent and Celestin Blue(CB) in acidic medium. The colored species has an absorption maximum at 525 nm for Imipenem and obeys beer’s law in the concentration range 0.008 – 0.048 μg/mL of Imipenem. The apparent molar absorptivity was 53x10-3 and sandell’s sensitivity was 7x10-3. The slope was 1.805 ± 0.02774 and intercept of the equation of the regression line are 0.02964 ± 0.02001. The optimum experimental parameters for the reaction have been studied and the validity of the described procedure was assessed. Statistical analysis of the results has been carried out revealing high accuracy and good precision. The proposed method was successfully applied for the determination of Imipenem in pharmaceutical formulations. The RP-HPLC method gave accurate and precise results in the concentration range of 10.08 to 100.80 μg/mL. The mobile phase composition consists of (60:40 v/v) of Methanol and milli-Q water containing 0,1 % orthophosphoric acid at the flow rate of 0.6 ml/min. The retention times of the drug are 3.18 ± 0.1 minutes. The column is Agilent Polaris 150 X 4.6mm, C18 column with the particle size of 5μm. A rapid sensitive and specific method for the determination of Imipenem in the pharmaceutical formulations has been developed.

Keywords: Imipenem, N-Bromo Succinamide(NBS), Celestin Blue(CB), Spectrophotometry, RP-HPLC method Orthophosphoric acid, Methanol.