SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF CEFUROXIME SODIUM AND SULBACTAM SODIUM IN INJECTONAbstract
Cefuroxime is a 2nd-generation cephalosporin and Sulbactam is a β-Lactamase inhibitor. The combination formulation is used for the treatment of lower respiratory tract infection. Two new, simple, accurate and precise UV spectrophotometric methods have been developed and validated for the simultaneous determination of Cefuroxime Sodium (CEF) and Sulbactam Sodium (SUL) in their combined dosage forms. First method is based on simultaneous estimation of Cefuroxime at 279nm and Sulbactam at 259 nm, while other Q‐absorption Ratio method using two wavelengths, 259nm (λmax of SUL) and 272nm (Isoabsorptive point). 0.01 N NaOH was the solvent used in all methods. Cefuroxime Sodium showed linearity in the range of 8-32μg/mL and Sulbactam sodium showed linearity in the range of 4-16μg/mL in all the methods. All methods were validated statistically and recovery studies were carried out. All methods were found to be accurate, precise and reproducible. These methods were applied to the assay of the drugs in marketed formulation, which were found in the range of 98.0% to 100.0% of the labelled value for both Cefuroxime and Sulbactam. Hence, the methods herein described can be successfully applied in quality control of combined pharmaceutical dosage forms.
F.M. Patel, J. B. Dave and C. N. Patel
Department of Quality Assurance, Shri Sarvajanik Pharmacy College, Mehsana-384001, Gujarat, India
24 April, 2012
14 May, 2012
21 August, 2012
01 September, 2012