Determination of Residual Ceftazidime in Pharmaceutical Product line: A Cleaning Validation Study by HPLC

The manufacturing equipment in pharmaceutical industry, could be used in multiple and sharedproduction lines, therefore there is the possibility for the products components and active ingredients tointermix and pollute one another. In this purpose the cleaning methods are used, to reduce the residueslevels from the machinery surfaces and decrease the residues to acceptable level but these methodsmust be validated firstly. This study aimed to validate the cleaning process of ceftazidime using a newmethod for determination of ceftazidime on equipment surfaces. In this order High Performance LiquidChromatography (HPLC) has been developed and relative samples have been analyzed. Through thisprocess, type and ratio of the buffer, flow rate and the pH were used as the effective factors in threelevels of design for the experiment, and a total of 27 exercises according to Box-Behnken model weredesigned and implemented. One of these experimental runs was picked and selected by software as theoptimum condition in accordance with the separation processes results and the validation of method hasbeen studied and researched. Validation process results proved the accuracy of the analysis method used,demonstrating it could be deployed to determine the level of ceftazidime in low dosages. Therefore:LOQ = 0.63 ppm, LOD = 0.17 ppm, and recovery percentage were reached to 100:71. The results of ourstudy demonstrated the developed method which is appropriate to hold optimal conditions for analysisof cleaning samples containing ceftazidime through HPLC process.