RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE IN COMBINED PHARMACEUTICAL DOSAGE BY ANALYTICAL QBD

Divyesh Vanparia*, Ronak Dedania and Zarna Dedania

A high-performance liquid chromatographic approach was developed and validated in order to gauge the effectiveness of three antiviral drugs in a combined pharmaceutical dosage form: Abacavir (ABA), Dolutegravir (DOLU), and Lamivudine (LAMI). For the intent of simultaneous drug quantification, the Analytical Quality by Design (AQbD) RP-HPLC method evolved using the Box-Behnken Design and the Design Expert® software (Version 11.0). The optimal conditions for the mobile phase's composition Methanol: Acetonitrile: Buffer of phosphate pH 3.5, 50:20:30 % v/v/v Using a Shimadzu C18 column on an HPLC system incorporating ultraviolet (UV) illumination at 230 nm was employed. The number of theoretical plates and the asymmetry factor reside within the bound. The suggested means was validated by obeying to the ICH standard. There are no findings of excipient involvement in the drug mixture assay. The computed percentage RSD was discovered in the acceptance criteria, demonstrating the accuracy, precision, and reproducibility of the procedure.