Selective Determination of Entecavir in the Presence of its Oxidative Degradate by Spectrophotometric and Chromatographic Methods

Abstract Background Entecavir (ENT) is an antiretroviral agent prescribed for the treatment of hepatitis B virus(HBV) and human immunodeficiency virus(HIV). Objective Development validation three simple, sensitive, selective, precise methods determination ENT in presence its oxidative degradation product (ENT deg.). Method The first method was based on second derivative (D2) spectrophotometry through measuring peak amplitude D2 spectra at 293.6 nm. one mean centering ratio (MCR), which enabled measurement 280.0 third HPLC, where separated from deg. using a Zobrax C18 column methanol:water (30:70, v/v) with pH 3 as mobile phase. developed were validated according to International Conference Harmonization guidelines. Results Linearity range 5.00–50.00 μg/mL both MCR. However, higher sensitivity achieved HPLC (1.00–50.00 μg/mL). Accuracy 100.60 ± 0.547%, 101.55 1.2071%, 100.61 1.207% D2, MCR, methods, respectively, precision within 1.280. Conclusions successfully applied Tecavir® tablets without interference They showed no significant difference comparison official they can be quality analysis high selectivity, accuracy, precision. Highlights quantified two spectrophotometric (D2 MCR) proposed sensitivity, accuracy.