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

Document Type: Original Article

Authors

1 Pharmaceutical Sciences Research Center, Islamic Azad University- Pharmaceutical Sciences Branch, (IAUPS), Tehran, Iran

2 Dept. of Pharmaceutics, Islamic Azad University, Pharmaceutical sciences Branch, Tehran, Iran

3 Afa Chemi Pharmaceutical Company, Tehran, Iran

Abstract

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

Keywords