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

Abstract

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