Abstract

DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF MOXIFLOXACIN AND PREDNISOLONE ACETATE IN PHARMACEUTICAL PREPARATION

Pinal B. Patel* and Satish A. Patel

Abstract

A simple and sensitive first order derivative spectrophotometric method was developed for the simultaneous estimation of Moxifloxacin and Prednisolone Acetate in pharmaceutical dosage form. The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The first order derivative spectra was obtained in methanol and the determinations were made at 258 nm (ZCP of Moxifloxacin) for Prednisolone Acetate and 303 nm (ZCP of Prednisolone Acetate) for Moxifloxacin. The two drugs comply with beer’s-lambert’s law over the linearity range of 2-40 μg/ml for Moxifloxacin and 5-80 μg/ml for Prednisolone Acetate. The method was validated as per ICH guidelines in terms of linearity, accuracy (recovery study), precision (repeatability, intraday, interday precision), limit of detection and limit of quantification. All the validation parameters were found to be within acceptable limits. The method was found to be simple, sensitive, rapid, cost effective, accurate and precise for the routine analysis of both the drugs in pharmaceutical dosage form.

Keywords: Moxifloxacin, Prednisolone Acetate, First order derivative spectrophotometric method, Zero crossing point, Pharmaceutical dosage form, Validation.