Development of RP-HPLC-PDA Method Validation for the Simultaneous Estimation of Zidovudine, Lamivudine, and Nevirapine in Bulk and Dosage Forms and in Dissolution Samples

Abstract

The purpose of this research is to design a rapid, efficient, and cost-effective RP-HPLC-PDA for the simultaneous determination of Nevirapine (NVP), Lamivudine (LMV), and Zidovudine (ZDV) in bulk, dosage forms, and dissolving samples. The maintained chromatographic conditions were an Inertsil ODS3 column (150×4.6mm,5µm) with 15mM Ammonium acetate: Methanol (55:45 v/v) as a mobile phase, injected in isocratic mode at flow-rate 1mL/min, eluents were measured at 270nm. LMV, ZDV, and NVP were eluted at 2.24, 3.88, and 8.15 minutes, respectively, under these LC conditions. At concentrations ranging from 5 to 25µg/mL, LMV (R2 = 0.999), ZDV (R2 = 0.997), and NVP (R2 = 0.996) exhibited excellent linearity. The LOD and LOQ for LMV were 0.296µg/mL and 0.899μg/mL, respectively, for ZDV were 0.105μg/mL, 0.320μg/mL and NVP were 0.113μg/mL, 0.343μg/mL respectively. In every instance, the validation acceptance criteria for variables such as accuracy, precision, assay, linearity, specificity, and robustness were met. The validated approach was utilized well for estimation of LMV, ZDV, and NVP in bulk, dosage forms, and dissolution samples.