ANALYTICAL METHOD VALIDATION AND BIOEQUIVALENCE STUDY OF ERLOTINIB 150 MG TABLETS IN IRANIAN HEALTHY VOLUNTEERS UNDER FASTING CONDITION

Objective: This study aims to compare a generic formulation of the drug erlotinib 150 mg tablet brand-name version validate analytical method and bioequivalence studies. Methods: Erlotinib hydrochloride tablets (test versus reference formulation) were compared in randomized, two-period crossover determine their pharmacokinetic properties healthy Iranian volunteers. 14 d passed between each treatment during washout period. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was used analyze erlotinib, validation is presented. Results: Over range 6.25-3200 ng/ml, verified as linear (R2= 0.998). The technique also accurate precise at various concentrations. results showed that pharmacokinetics two products comparable. Following administration test products, geometric averages for (Area under curve) AUC0-72, AUCinf, maximum plasma concentration (Cmax) 104.71 (90% CI, 93.39-117.40), 104.68 93.47-117.23), 104.85 94.61-116.21), respectively. outcomes fell within permitted tolerance 0.8 1.25. Conclusion: For determination plasma, approach accurate, precise, repeatable, selective. Additionally, research revealed no appreciable differences characteristics products. Therefore, it possible assert product are bioequivalent.