DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF CEFIXIME AND OFLOXACIN IN THEIR COMBINED TABLET DOSAGE FORM

Abstract

A simple, accurate and rapid high performance thin layer chromatography (HPTLC) -densitometry method was developed for separation and determination of cefixime (CEF) as an oral third generation cephalosporin antibiotic and ofloxacin (OFL) as a fluoroquinolone derivative used as antibacterial in pharmaceutical dosage forms. The compounds were separated on silica gel 60 GF254, HPTLC plates using a mixture of methanol: ethylacetate: ammonia solution (25%) (4:4.5:1.5 V/V/V) as the mobile phase. Compact spots of both cefixime (Rf=0.46±0.01) and ofloxacin (Rf=0.59±0.01) were obtained. A UV detection was performed at 295 nm. The method was validated in terms of linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). The calibration curves were linear in the range of 100-600 ng/spot for both drugs. For CEF recovery varied in range of 100.13-100.25% with % RSD0.21-0.31% and for OFL recovery varied in range of 99.61-99.89 % with% RSD0.24-0.38%. The LOD was found to be 25.45 ng and 32.42 ng spot for CEF and OFL, respectively. The LOQ was found to be 77.14 ng and 98.26 ng /spot for CEF and OFL, respectively. It was observed that the proposed HPTLC method could be used for efficient analysis and monitoring of the CEF and OFL in combined tablet dosage forms.