Abstract

VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) METHOD FOR DETERMINATION OF ERLOTINIB RELATED SUBSTANCE IN PHARMACEUTICAL DOSAGE FORM

Farzana Hasin*, Al Amin, Md. Iftekhar Hussain, Tajdika Jahan and Nafreen Akther Hama

Abstract

A simple HPLC method was developed and validated for detection & quantitation of Erlotinib related substances which may co-exist in solid pharmaceutical dosage forms. The HPLC separation was achieved on a YMC-Basic; 3μ, 150 × 4.6 mm column using mobile phase of Mobile phase A-Water :Tetrahydrofuran : Trifluroacetic acid (965:35:1.5) ; Mobile phase B-Water: Actonitrile: Tetrahydrofuran: Triflurocetic acid (460:460:80:1.5) at a flow rate of 1.5 ml/min. The UV detector was operated at 245 nm, and column temperature was adjusted at 50 °C. The method was validated for specificity, linearity, precision, accuracy, robustness, limit of detection andquantitation. The degree of linearity of the calibration curves, the percent recoveries of Erlotinibrelated substances, the limit of detection and quantitation, for the HPLC method were determined. The method was found to be simple, specific, precise, accurate, and reproducible. The method was applied for the quality control of commercial Erlotinib tablets to quantify its related substances.

Keywords: Erlotinib, HPLC, Observation.