STABILITY INDICATING RP- HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF CEFIXIME AND CLOXACILLIN FROM PHARMACEUTICAL FORMULATION

Pralhad Rege* and Avinash Jagdale

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 Cloxacillin from combined pharmaceutical drug formulation. Chromatographic separation of Cefixime and Cloxacillin 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 10-200 μg/mL for Cefixime and 25-500 μg/mL for Cloxacillin with correlation coefficient greater than 0.999 for both the analytes. The total eluting time for the both components is less than five 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 Cloxacillin in combined pharmaceutical drug formulations.

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