Spectrophotometric method development and validation for simultaneous quantification of Cefoperazone and Sulbactum sodium in bulk and marketed formulation: greenness profile evaluation

Abstract

The antibiotics Cefoperazone Sodium and Sulbactam Sodium are widely employed in clinical medicine as means to combat many kinds of bacterial infections. The drugs Cefoperazone and Sulbactum shows wavelength at 229 m and 277 nm respectively in solvent of 1 % glycerol, 1 % 0.1 M NaOH in distilled water. The methods proposed on UV spectrophotometric technique are the Simultaneous Equation Method, Q-Absorbance Ratio Method, Absorbance Subtraction Method, and the Area Under Curve Method (AUC). Using original stock solutions, their linear range extended from 5 to 25 µg/mL for CEF, and from 10 to 50 µg/mL for SUL with correlation coefficient is greater than 0.99. The methods are validated as per the ICH Q2 (R1) guidelines. The average recovery rates ranging from 100.34 % to 100.92 %. The results demonstrate accuracy, linearity and precision and the methods showed successful application in the quantification of the components under study in the commercially available dosage form with no interference from the matrix excipients. Six green metrics were used to evaluate the environmental impact of the extraction procedure, using Analytical Greenness (AGREE) metric algorithm shows score of 0.83 based on the green analytical chemistry framework. Analytical Eco-Scale scored 92 which is excellent greenness, the method is also assessed with AGREEprep, Complex Green Analytical Procedure Index (Complex GAPI), Assessment of Green Profile (AGP), and National Environmental Methods Index (NEMI) and found greenness compared with the reported method.