High-performance liquid chromatographic determination of polysorbate 80 in pharmaceutical suspensions.

A quick HPLC method is reported for the analysis of polysorbate 80 in pharmaceutical suspensions. A typical pharmaceutical suspension was mixed with dilute potassium hydroxide, and heated at 40 degrees C for 6 h. This procedure resulted in quantitative hydrolysis of polysorbate 80 to release oleic acid. A quick HPLC procedure was used to analyze the hydrolyzed samples without further sample treatment. Polysorbate 80 USP, treated in the same way as the pharmaceutical suspensions, was used as standard. Full validation tests were carried out and the validation studies demonstrated that this method is suitable for accurate and reproducible analysis of polysorbate 80 in pharmaceutical suspensions.