Validation of a cleaning method for a veterinary drug using high-performance liquid chromatography

Identifier:  TFG:10061

Handle: https://hdl.handle.net/20.500.11797/TFG10061

Authors:  Colell Amposta, Ainoa

Abstract:
Pharmaceutical laboratories work according to quality standards to ensure that medicines are safe, effective, and of high quality. To achieve this, and in compliance with Good Manufacturing Practices, all procedures such as manufacturing processes, cleaning, analytical methods, etc., must be properly validated. This study is focused on the validation of a cleaning method to determine two active principles (PA1 and PA2) found in a veterinary medicinal product. High-performance liquid chromatography (HPLC1 ) is used to ensure the complete clean-up of the traces of these compounds in the production equipment. Several analytical parameters, such as the selection of chromatographic conditions and the study of linearity, have been established and optimized to achieve a reliable and robust method. This validation is essential to comply with quality regulations in veterinary drug production and to ensure animal safety.