New HPLC and UHPLC Assay Methods for TC-HCl and 4-EATC Impurity in TC Drug Products

Read this study which shows how HPLC and UHPLC methods can be used to assay TC and EATC in a TC-HCl capsule. The results from both methods meet or exceed the criteria in the appropriate USP monographs. Both methods are faster and show higher resolution than the current methods. They also generate less waste and use less hazardous organic solvents. These methods may be applicable to other TC-HCl-containing drug products.