A Validated RP-HPLC Method for Simultaneous Quantification of Abacavir and Zidovudine and their Impurities in Combined Dosage Forms

Abstract

Develop a simple, accurate, and precise method for simultaneous analysis of Abacavir and Zidovudine, along with their related impurities, in combined pharmaceutical dosage forms. A reverse- phase high-performance liquid chromatography (RP-HPLC) method was developed using an LC-20 AT C18 column and a Water: Methanol (80:20) mobile phase. Detection was carried out at 240 nm. The method successfully separated Abacavir, Zidovudine, and their respective impurities with distinct retention times. Validation demonstrated good linearity, accuracy, and precision for both drugs and their impurities. Limits of detection (LOD) and quantification (LOQ) were determined and found to be suitable for analyzing impurities in commercial dosage forms. The developed RP-HPLC method offers a simple, accurate, and reliable tool for simultaneous quantification of Abacavir, Zidovudine, and their impurities in combined dosage forms, thereby contributing to quality control and ensuring drug safety. Keywords Abacavir, Zidovudine, Related Substance RP-HPLC Method, ICH Q2 (R1) guidelines