Formulation And Development Of Hplc Validation For The Simultaneous Estimation Of Antibacterial Agents

Abstract

A very sensitive, precise, accurate, robust, and repeatable RPHPLC technique was developed for the detection of cefpodoxime proxeti. This approach does not incorporate any sample excipients or degradants whatsoever. The method was developed by employing a mobile phase composed of a buffer containing 20 mM potassium dihydrogenphosphate, methanol, and acetonitrile. The separation was performed using a Hypersil keystone RP C18 column at a flow rate of 1.2 ml/min with a wavelength of 235 nm. During a 25-minute run, the R and S isomers of cefpodoxime proxetil exhibited peaks at 13.11 and 14.12 minutes, respectively, while the peak for ofloxacin occurred at 5.01 minutes. Based on this approach, the levels of cefpodoxime proxetil in Zedocef O tablets are 99.8% and 99.2%, respectively. The RSDs (Relative Standard Deviations) of 0.0708 and 0.596 for Cefpodoxime Proxetil and Ofloxacin, respectively, were deemed acceptable. The suggested method was validated by adhering to the ICH standards. The cefpodoxime proxetil and levofloxacin standards were found to be 80%, 100%, and 120% of the specified quantity. This contributed to assessing the precision of the testing procedure. The mean percentage recoveries for Cefpodoxime Proxetil and Levofloxacin were 99.67% and 99.69% respectively at the 80% concentration level, 99.65% and 99.75% respectively at the 100% concentration level, and 99.69% and 99.65% respectively at the 120% concentration level. All of the relative standard deviation (RSD) percentages observed in investigations on effective recovery fell within acceptable bounds, with no values exceeding 2 percent for both RSD and percent assay deviation. This approach demonstrated a linear connection between cefpodoxime proxetil concentrations ranging from 2 to 24 ng/ml and levofloxacin concentrations ranging from 2.5 to 30 ng/ml (r 2 = 0.9999). Linear correlations were observed between levofloxacin concentrations ranging from 2.5 to 30 ng/ml.

Keywords: HPLC, Cefpodoxime, Levofloxacin, Ftir, In-Vitro