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< 0.30%) were found within acceptable limits. Furthermore, the prescription drug was exposed to oxidation, reduction, photolysis, hydrolysis (acid, basic and neutral) and heat degradation. There is evidence that the suggested technique can stability indicating of the drug by separating it from the degradation products that result from its stress study. The efficiency of the suggested stability-indicating method is demonstrated by the forced degradation study’s results. The analysis of the cited medicine, EV, was accomplished successfully using the validated RP-HPLC method.