Abstract

STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF CIPROFLOXACIN AND FLUOCINOLONE IN BULK AND LIQUID DOSAGE FORM

Aruna Gundala*, Arun Kumar V. and Nanda Kumar K. V.

ABSTRACT

The present study was designed to develop and validate a simple, sensitive, precise and accurate stability indicating RP-HPLC method for simultaneous estimation of Ciprofloxacin and Fluocinolone in bulk and liquid dosage form. The chromatographic separation was achieved on Zodiac C18 (4.6 x 150mm, 5μm) as stationary phase with a mobile phase of 0.1% OPA: acetonitrile (60:40 v/v) at a flow rate of 1 ml/min and PDA detection at 246 nm. The proposed method was validated for system suitability, specificity, linearity, accuracy, precision, LOD, LOQ and robustness as per ICH guidelines. The retention times of Ciprofloxacin and Fluocinolone were found to be 2.324± 0.04 and 3.320± 0.06 min respectively. The calibration curves were linear in the concentration range of 25% to 150% of the working concentration (r2=0.999) for both the drugs in binary mixture. The accuracy was found to be 99.26% and 99.14% for Ciprofloxacin and Fluocinolone respectively. The LOD was found to be 0.04μg/ml and 0.05μg/ml and LOQ was found to be 0.11μg/ml and 0.16 μg/ml for Ciprofloxacin and Fluocinolone respectively. The percentage recoveries for both drugs were in the range of 99-100%. The method was applied for determination of Ciprofloxacin and Fluocinolone in the presence of their degradation products under the variety of stress conditions. The pharmaceutical ingredient was subjected to acid, alkali, water, heat, UV light and oxidative stress conditions and stress samples were analysed by the proposed method. Hence the proposed stability indicating RP-HPLC method can be used in routine analysis of ear drops containing Ciprofloxacin and Fluocinolone.

Keywords: Ciprofloxacin, Fluocinolone, Ear drops, RP-HPLC, Stability, Method development and Validation.