Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF ERLOTINIB HYDROCHLORIDE

U. Mohan Kumar, P. Sravanthi, S. Lakshmi Naga Aparna, G. Tejaswi and I. Theja*

Abstract

In the present study, a reliable and efficient reverse-phase highperformance liquid chromatography (RP-HPLC) method was established for the quantitative estimation of Erlotinib Hydrochloride. Chromatographic separation was achieved using a Phenomenex C18 column (250 mm × 4.6 mm, 5 μm), with a mobile phase composed of acetonitrile and phosphate buffer in an 80:20 (v/v) ratio. The pH of the buffer was adjusted to 5.0 using orthophosphoric acid. The analysis was carried out at a flow rate of 1.0 mL/min, and detection was performed at 245 nm. Erlotinib exhibited a retention time of 3.7 minutes, confirming the rapidity of the method. The calibration curve showed good linearity within the concentration range of 1–6 μg/mL. The limit of detection (LOD) and limit of quantification (LOQ) were determined to be 0.01 ng/mL and 1 ng/mL, respectively. Method validation was conducted following ICH Q2(R1) guidelines, demonstrating its accuracy, precision, and suitability for the intended purpose. This validated method was effectively applied for the routine estimation of Erlotinib HCl in both bulk drug and pharmaceutical formulations.

Keywords: Erlotinib HCl, HPLC, Validation, ICH Guidelines, Method development.