Optimization and Validation of a Green Shelf Life HPLC Technique for Testing Sugammadex Sodium in Raw Material and Parenteral Medications.

An intravenous drug called sugammadex is used to counteract the adverse reactions of the relaxation medications rocuronium and vecuronium, which are given during operations to provide full anesthesia. The principal objective of the presented study is developing and validating a complete, innovative, fast, isocratic, and green shelf life liquid chromatography methodology, Sugammadex sodium levels in injectable therapies can now be measured. A number of tests were performed on sugammadex sodium in accordance with ICH guidelines. Sugammadex sodium and its related degradants were effectively separated via isocratic separation. At ambient conditions, the Zorbax SB ODS stationary phase was used to quantify and validate the drug substance. The isocratic mobile phase runs at a flow rate of 1.0 mL/min. It includes the eluting phase that comprises of 7 mL/L aqueous solution of triethylamine adjusted at pH 3.0 with phosphoric acid: ethanol (750:250) (V:V). The positive environmental impacts of the LC technique are demonstrated by the combined AES grade of 87, CACI rating of 78, AGSA rating of 75, MoGAPI rating of 80, BAGI rating of 82.5, and final whiteness rating of 96.7.