Analytical Method Development and Validation for Impurity Profiling of Bictegravir as an Antiretroviral Drug

An innovative analytical approach for the thorough impurity profiling of the key antiretroviral medication Bictegravir was developed and validated in this work. The approach was very precise in its ability to isolate and resolve Bictegravir from its constituent contaminants. Thorough evaluations of peak purity verified that there was no co-elution, guaranteeing that each peak reflected a distinct component. Extensive evaluation of precision at the limit of quantitation (LOQ) demonstrated that the approach could consistently and reliably quantify Bictegravir and its contaminants. Specificity, accuracy, precision, and resilience were some of the critical performance metrics that were thoroughly tested during the validation process. The findings confirm the method's accuracy and dependability, guaranteeing the drug substance's safety and purity. With this proven analytical approach, pharmaceutical quality control will be a breeze. It will help with exact monitoring of Bictegravir's concentration and purity in different medication formulations, which means the medicine will be used safely and effectively.