Browsing by Author "Sosu, Jerry Xola"

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    Development of an HPLC Method for the Chemical Quality and Cleaning Validation of Cephalosporin Products
    (2011) Sosu, Jerry Xola
    A new cost effective HPLC method of analysis has been developed to assay separately and simultaneously these compounds; cefuroxime (injection), ceftriaxone (injection) and cefepime (injection). 80% Phosphate buffer and 20% methanol as mobile phase with C18 reverse phase column; Zorbax ODS (C18) - 4.6mm x 25cm was used. The detector used was UV-Vis with a wavelength of 260nm. The flow rate and the injector volume were 1.5ml/min and 20μl respectively. Diluents was methanol ( 80% phosphate buffer in the ratio 1:4). The results were analyzed statistically using ANOVA, T-test and F-Test. At 95% confidence level, the method is robust. The average retention time for Cefepime, Ceftriaxone and Cefepime were 4.78min ± 0.016, 5.87 ± 0.039 and 15.39 ± 0.026 respectively. The percentage recovery for respective cephalosporin injections in the assay performed at the three different concentration levels were greater than 98% and their relative standard deviation were less than 2% and within acceptable limits of accuracy. The linear regression analysis results showed a correlation coefficient of about 0.99 for each calibration plot. This gave an indication of good linear relationship between instrument response and analytes concentration in the range 30μg/ml to 120μg/ml for each cephalosporin analytes. The limit of Quantification (LOQ) and limit of Detection (LOD) based on instrument response were as follows Cefepime: LOQ – 0.003933mg/ml and LOD – 0.001180mg/ml; Ceftriaxone: LOQ - 0.001595mg/ml and LOD - 0.0004786mg/ml. and Cefuroxime: LOQ – 0.0007239mg/ml and LOD – 0.0002172mg/ml. The HPLC method of analysis can effectively assay separately and simultaneously cefuroxime, ceftriaxone and cefepime products and hence had performance of the developed method as a validation procedure for cleaning of equipments after manufacturing the cephalosporin products assured at confidence level of 95%.