RP-HPLC can be used to determine an Enfortumab vedotin monoclonal antibody drug conjugate for treating urothelial cancer in an efficient rapid and quantitative manner

Enfortumab vedotin (EV) is an antibody-drug conjugate that’s applied to the treatment of urothelial carcinoma, or bladder cancer. EV was a microtubule-disrupting chemotherapeutic drug and human monoclonal antibody. The current research study used to develop the RP-HPLC technique with a photodiode array detector to set up a reliable, stability-indicating, rapid method for drug determination. By utilizing this technique, the final chromatographic conditions were achieved with a column Waters X-Terra RP-18 (250 mm x 4.6, 5 μm), and a mobile phase made with acetonitrile and 0.0149 M ammonium acetate buffer (pH-3), 5: 5 ratio, respectively by adopting isocratic elution. EV was detected at 271nm, and a satisfactory separation was achieved within 5.0 minutes of runtime with a flow rate of 1.0 mL/min. The method is linear from 25-150 μg/mL for EV (R2= 0.9998). Results of precision for EV (%RSD