Validated Spectrophotometric Method for Determination of Polymaxin-B Sulfate in Pharmaceutical Formulations

Abstract

Objective:The simple and selective spectrophotometric method have been proposed for the determination of PMBS, in pure form and their pharmaceutical formulation.

Method: The method is based on the formation of color complex between ferric chloride and PMBS, actually, vanillin forms imine in the presence of buffer at 60c-70c with PMBS. The imines are the good legends for transition metals. Here the green color is the color of complex of iron and PMBS, WHICH absorbs EMR at 600nm.

Results:Different variables and parameters affecting the reaction was studied and optimized. Beers plots were obeyed in a general concentration range 50ppm – 0.5mg/ml with co-relation co-efficient not less than 0.9991.The proposed method was successfully applied to the analysis of the cited drugs in their dosage forms.

Conclusion:The proposed method was validated according to ICH and USP guidelines with respect to specificity Linearity, accuracy, precision, robustness and ruggedness.