Abstract

STABILITY INDICATING RP- HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF CEFIXIME AND OFLOXACIN FROM PHARMACEUTICAL DOSAGE FORMULATION

Pralhad Rege*, Avinash Jagdale and Amol Kulkarni

.

Abstract

In present study, a successful attempt has been made to develop a simple, sensitive and validated RP-HPLC method for the simultaneous determination of Cefixime and Ofloxacin from combined pharmaceutical drug formulation. Chromatographic separation of Cefixime and Ofloxacin was achieved with gradient elution on C-18 column with mobile phase A- 0.1% formic acid in Water and mobile phase B- 0.1% formic acid in Methanol at a wavelength 250 nm. The method was validated in the terms of its linearity, accuracy, precision, robustness, ruggedness, LOD and LOQ. Linearity of the method was found to be in the concentration range of 5-200 μg/mL for Cefixime and 5-200 μg/mL for Ofloxacin with correlation coefficient greater than 0.999 for both the analytes. The total eluting time for the both components is less than seven minutes. Proposed method was found to be simple, precise, and accurate and can be successfully applied for routine quality control analysis and simultaneous determination of Cefixime and Ofloxacin in combined pharmaceutical drug formulations.

Keywords: RP-HPLC, Cefixime, Ofloxacin, Pharmaceutical drug formulations and Validation.