Abstract

NEWER ANALYTICAL METHOD DEVELOPMENT OF ERLOTINIB HYDROCHLORIDE AND STUDY OF IN VITRO DRUG-DRUG INTERACTION WITH PROTON PUMP INHIBITORS

Nagaraj N. Durgadasheemi*, Kavitha S. K., Shilpashrre A. T. and Syed Nizamuddin

ABSTRACT

In the present work, newer analytical methods for the determination of Erlotinib hydrochloride has been developed, stability of Erlotinib hydrochloride is determined by performing stress degradation studies and in vitro drug-drug interaction of Erlotinib hydrochloride with PPIs was studied. A simple, precise RP-HPLC method was developed and validated for estimation of Erlotinib hydrochloride using C18 column maintained at constant temperature and UV wavelength was at 254 nm. The mobile phase consists of acetonitrile (A) and Phosphate buffer (B) (50:50 v/v). The isocratic mode was employed at flow rate of 1 ml/min and injection volume of 20 μl. The method has been validated using ICH guidelines. In vitro drug-drug interaction study was performed for Erlotinib hydrochloride with three different PPI at pH 1.4, 2.4 and 4.5 in aqueous medium and in plasma.The retention time of Erlotinib hydrochloride in mobile phase A and B (50:50 v/v) was found 5.31 min. The linearity of standard Erlotinib hydrochloride was obtained in the range of 10-100 μg/ml. The % RSD for precision is less than 2%. After performing in vitro drug-drug interaction study at pH 1.4, pH 2.4 and pH 4.5, the observed result is no shift in the Rt of the Erlotinib hydrochloride in different pH and in combination with PPI in aqueous medium and in rat plasma. The developed analytical conditions were with good resolution within short analysis time. From the obtained results, it can be concluded that Erlotinib hydrochloride does not form any stable complex with PPI. Therefore, mentioned results may consider during monitoring and concurrent therapy of both drugs. Thus the developed method can be used for the routine analysis of Erlotinib hydrochloride in laboratories, clinical trails and quality control purpose.

Keywords: Erlotinib- Erlotinib hydrochloride, PPI- Proton pump inhibitors.