Abstract

DEVELOPMENT AND VALIDATION OF ZERO ORDER UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF PEFLOXACIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Malathi Raghunath*, Shweta Patil and Amol Dhamne

ABSTRACT

A new, simple, accurate, precise, reproducible and economical zero order UV spectrophotometric method for estimation of Pefloxacin Mesylate in bulk and tablet formulation has been developed. The method of single point standardization was used for quantitative estimation of pefloxacin mesylate and absorbance was determined at 288nm (λmax of pefloxacin mesylate) using methanol as solvent system. The solutions of pefloxacin mesylate obeyed Beer’s law in concentration range of 2-20 μg/ml. The method was validated for parameters such as linearity, accuracy, precision and limit of quantification, limit of detection, ruggedness and robustness as per ICH guidelines. The developed and validated method was used for determining the content of pefloxacin mesylate in commercial tablets containing 400mg of pefloxacin mesylate. The proposed method was thus found suitable for quantitative estimation of pefloxacin mesylate in bulk and tablet formulations without any interference of the excipients.

Keywords: Pefloxacin Mesylate, Validation, Single point standardization, ICH guideline.