European Journal of Biomedical and Pharmaceutical Sciences

METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF AMBROXOL AND CEFPODOXIME BY RP-HPLC METHOD IN BULK AND PHARMACEUTICAL DOSAGE FORM

M. Navaneetha*, Dr. Paul Richards M., Dr. V. Kiran Kumar and P. Govardhan Reddy

ABSTRACT

The Present work was to develop a simple, fast, accurate, precise, reproducible, reverse phase high performance liquid chromatographic method for simultaneous estimation of ambroxol and cefpodoxime in pharmaceutical tablet dosage form marketed as doxinate. Chromatographic separation was done using Inertsil ODS RP C18 column having dimension of 4.6×250mm having particle size of 5μm, with mobile phase consisting of phosphate buffer pH 3 ±0.02 pH adjusted with ortho phosphoric acid and acetonitril (50:50 %v/v), flow rate was adjusted to 1.0 ml/min and detection wavelength at 263nm. The retention times of ambroxol and cefpodoxime was found to be 2.35 and 4.80min. The Proposed method has been validated for accuracy, precision, linearity, range and robustness were within the acceptance limit according to ICH guidelines. Linearity for ambroxol and cefpodoxime was found in range of 25μg-150μg and correlation coefficient was found to be 0.999 and 0.999, %RSD for method precision was found to be 0.76, 0.82 and for system precision was 0.80 and 0.71 respectively, % mean recovery for ambroxol and cefpodoxime was found to be 99.18% to 99.48%. The method was found to be robust even by change in the mobile phase ±5% and in less flow condition. The developed method can be successfully employed for the routine analysis of ambroxol and cefpodoxime in API and Pharmaceutical dosage forms.

Keywords: Ambroxol and Cefpodoxime, RP-HPLC, Method development, Method validation.