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

Abstract

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