Abstract
The purpose of this research is to design and validate a unique, simple, and effective RP-HPLC analytical method using the QbD methodology. The QbD methodology not only confirms the method's robustness but also aids in the development of repeatable and reliable data. The goal of this work is to develop and validate a simple analytical RP-HPLC method for determining Cefpodoxime Impurity (Cefpodoxime Acid) in pharmaceutical formulations using the Analytical Quality by Design methodology (AQbd) in accordance with ICH Q8 guidelines. The Analytical Quality by Design technique was used in the proposed study. Cefpodoxime impurity (Cefpodoxime Acid) was chromatographically evaluated using an Inertsil C18 (5 m) column. The mobile phase was phosphate buffer and methanol pH 4.0 in the ratio of 60:40, which was driven onto the column at 0.8 ml/min using an isocratic elution protocol. 222 nm was discovered to be the detection wavelength for impurity estimation. Design expert 11 (Trial edition) software was used to investigate the effects of the mobile phase composition, flow rate, and pH. The analysis of cefpodoxime acid took 20 minutes to complete & at 15.6 minutes, the impurity was eluted.
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