Abstract

A RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ENROFLOXACIN AND KETOPROFEN IN MARKETED FORMULATION

G. Indira Priyadarshini*, Pondugala Mounika, Nagaraju Pappula and V. Mounika

.

Abstract

A simple, fast, new, precise, sensitive, and accurate RP-HPLC method was developed and validated according to ICH guidelines for the estimation of Enrofloxacin and Ketoprofen in bulk and marketed formulation. Chromatographic separation was achieved using a Shimadzu HPLC system with an Inertsil ODS C18 column (4.6mm × 250mm i.d., 5μm particle size). Best results were obtained with the mobile phase composition consisting of 0.1% trifluoroacetic acid, methanol, and acetonitrile in a ratio of 20:40:40v/v. The system was regulated at a 0.7mL/min flow rate at an optimized wavelength selected for detection at 262nm. The retention times for Enrofloxacin and Ketoprofen were 2.941 and 5.756 minutes, respectively. The method has been validated for linearity, accuracy, precision, LOD, LOQ, and robustness as per ICH guidelines. The calibration graphs were linear over the concentration range of 10-50μg/mL for Enrofloxacin and 6-30μg/mL for Ketoprofen. The LOD results for Enrofloxacin and Ketoprofen were 1μg/mL and 0.6μg/mL, and the LOQ results for Enrofloxacin and Ketoprofen were 3μg/mL and 1.8μg/mL, respectively. The result of the analysis shows that the %RSD will be less than 2 for all the validation parameters, and recovery studies showed that the outcomes fell within the specified limits. Hence, the proposed method was found to be satisfactory and could be used for the routine analysis of Enrofloxacin and Ketoprofen in their bulk and marketed formulation.

Keywords: Enrofloxacin, Ketoprofen, RP HPLC, Method development, Method validation.