METHOD DEVELOPMENT AND VALIDATION OF CLEANING PROCEDURE FOR FENBENDAZOLE RESIDUAL DETERMINATION IN MANUFACTURING

Abstract

Objectives: Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients
of the product manufactured in a piece of equipment. All residues are removed to predetermined levels to ensure the quality of the next product.
Today, manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross
contamination, and as a good manufacturing practices requirement. The main aim of the study was to develop and validate a new simple, precise,
and accurate reverse phase high-performance liquid chromatographic (HPLC) method for fenbendazole (FBZF) residual determination in veterinary
active pharmaceutical ingredient manufacturing.
Methods: The method was developed using the isocratic solvent system, HPLC grade acetonitrile, and Mill-Q water in the ratio of 60:40 (volume/
volume), and 1% hydrochloric methanol is used as diluent. Successful elution of the FBZF was achieved on Waters Symmetry C-18 column with
250 mm×4.6 mm internal diameter and 5 μm particle size.
Results: The method validation was successfully applied for routine analysis for cleaning/residual samples. The developed reverse phase liquid
chromatography method was validated with respect to specificity, linearity, accuracy, precision, and high sensitivity with detection limits and
quantification limits ranging from 0.2 ppm to 15 ppm.
Conclusion: The present developed and validated method is run successfully for FBZF residual determination of cleaning samples in veterinary active
pharmaceutical ingredient manufacturing.
Keywords: Fenbendazole, Residual determination, Reversed phase high-pressure liquid chromatography and cleaning validation.