Stability Indicating Method Development Degradation Studies and Validation of Cefpodoxime Proxetil by RP-HPLC Method

Author(s)

Kamalesh, G., Madhuri, D., Nagarajan, G.

Author's Affiliation

Abstract

A new RP-HPLC method has been developed and validated for the stability studies of Cefpodoxime proxetil and detection of isomers. Degradation of products is produced through the process of degradation such as acid, base, heating, respectively. The experimental separation was carried out using  Hypersil  C₁₈( 250*4.6,5µm particle size) BDS column with a flow rate of 1.2ml/min and PDA  detector to detect the wave length at the 235nm.The mobile phase consists of  Acetonitrile and mixed phosphate buffer of pH 6.8  in the ratio of  65:35.validation parameters of precision and accuracy data for  Cefpodoxime proxetil and isomer of standard deviations(SD)  obtained were 0.002939388 and 0.007332121.The linear regression analysis data for the calibration curves for both  the plots showing linear relationship with the R² values of 0.9999 for CP and 0.998 for isomer with the concentration range of 50-200 µg/ml. The LOD and LOQ were estimated as 3.21 and 9.83µg/ml. Robustness and ruggedness trails obtained were 9.400 and 8.649, 8.304 and 9.005 for CP and isomer respectively .The standard peaks were produced by the retention time (RT) values of 9.299 and 8.204 Tailing factors were found to be below 2.The comparative studies of Assay was performed on drug and isomer to determine the standard deviation of samples and % assay were found to be 99.84% and 99.86% respectively.

Keywords

Cefpodoxime Proxetil, Isomer, Reverse- phase, HPLC, Retention time

Cite This Article

G. Kamalesh, Dr. D. Madhuri, & Dr. G. Nagarajan. (2014). Stability Indicating Method Development Degradation Studies and Validation of Cefpodoxime Proxetil by RP-HPLC Method. International Journal for Pharmaceutical Research Scholars, 3(4), 269-275.