Application of Design Space, Uncertainty, and Risk Profile Strategies to the Development and Validation of UPLC Method for the Characterization of Four Authorized Phosphodiesterase Type 5 Inhibitors to Combat Counterfeit Drugs

摘要: Background Counterfeit medicines are an increasing scourge that difficult to identify and they have become industrialized widespread through highly organized illegal channels. Objective This research aims develop a robust method determine four phosphodiesterase type-5 inhibitors in counterfeit drugs based on ultra-performance liquid chromatography. Method Experimental design methodology (DOE) space (DS) recommended by ICH Q8 were used side-by-side the development phase define optimal parameters as well robustness of chromatographic method. Moreover, both uncertainty risk profile derived from β-content γ-confidence tolerance interval investigated during validation examine performance this Results Successful results, high resolution between active ingredients analysis time less than 1.6 min, achieved at end optimization phase. In addition, results show low future measurements outside acceptance limits set 5%. Conclusions Our procedure was successfully applied routine 23 illicit formulations erectile dysfunction drug. Highlights An efficient for characterization 4 authorized min established. A DS approach test analytical development. then carried out approve validity approach.