Сloud point extraction coupled with HPLC-UV for the determination of ibuprofen residues on stainless steel surface of pharmaceutical manufacturing equipment

Abstract

A new application of cloud point extraction coupled with HPLC-UV was developed for the determination of ibuprofen residues on stainless steel surface of pharmaceutical manufacturing equipment. Some parameters with an effect on the cloud point extraction of ibuprofen, such as the concentration of Triton X-114, pH influence, incubation time, equilibration temperature, and centrifuging parameters, were studied and optimized. For optimal cloud point extraction solution of Triton X-114 with concentration 0.3% (w/v) and pH= 3.0 was selected. Wipes soaked with 0.001 M sodium carbonate solution were used to remove ibuprofen residues from stainless steel surfaces. The method was validated over a concentration range of 10–100 ng mL−1. The LOD and LOQ for ibuprofen were found to be 14 and 46 ng mL−1, respectively. Recoveries were 108.9%, 105.6%, and 104.9% with RSD ranging from 4.0% to 10.0% at three concentration levels.