TO VALIDATE STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF ASSAY OF LEVOFLOXACIN AND CEFPODOXIME DRUGS IN THE PHARMACEUTICALS TABLET FORMULATIONS USING LAMOTRIGINE AS A COMMON INTERNAL STANDARD

Shaikh Javed Shaikh Afzal*, Anis Ahmed and Pathan Mohd Arif Ali Khan

ABSTRACT

Levofloxacin is a synthetic broad-spectrum antibacterial agent administered orally and intravenously. Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. Validation of stability indicating Simple, Specific, Precise, Accurate, Linear, Rugged, Robust High Performance Liquid Chromatographic method of analysis for simultaneous determination of assay of Levofloxacin and Cefpodoxime drugs in the pharmaceuticals Tablet formulations using Lamotrigine as a common internal standard was performed. The assay was accomplished using a mixture of 0.1% Trifluoroacetic acid in Water and methanol in the volume ratio of 35:65 v/v as mobile phase on a Zorbax SB- C18, 150 mm x 4.6mm, 3.5μ as chromatographic column at a flow rate 0.700 mLmin-1 and with a uv detector at a wavelength 278 nm. The temperature of auto injector and column oven was 100C and 300C receptively. The Injection volume kept as 30 μL. linearity of the analytical method was evoluted at concentration range of 7.0041 μg/ml to 350.0350 μg/ml for Levofloxacin and 5.6048 μg/ml to 280.1050 μg/ml for Cefpodoxime respectively with Correlation coefficient (r) value more than 0.9999.The LOD and LOQ was 0.9135μg/ml and 2.7681μg/ml for Levofloxacin and 1.2387μg/ml and 3.7536μg/ml for Cefpodoxime respectively. The retention time found to be 5.01 min for Levofloxacin, 7.28 min for Cefpodoxime and 10.39 min for internal standard. Specificity, Method Precision, System Precision, Ruggedness, Robustness, Recovery, Stability of analytical solution, Filter paper selection study, Stress testing(Force Degradation) at various conditions were performed as per the ICH (Q2) recommendations. All the results were found with in acceptance criteria.

Keywords: Levofloxacin, Cefpodoxime Hydrochloride, Lamotrigine Hydrochloride, High Performance Liquid Chromatographic, Force degradation studies, Assay.