Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF ETOPHYLLINE AND THEOPHYLLINE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

V. G. Sakhare, M. D. Kolhe*, A. J. Giri and K. N. Khodke

Abstract

An HPLC-PDA method was developed and validated for the determination of hydrochlorothiazide in bulk and pharmaceutical formulation. The method was optimized selecting chromatographic conditions of 70: 30 acetonitrile : phosphate buffer, C18 column (ODS- 3 150 mm × 4.6 mm, 5 μm), 20μL injection volume, flow rate of 1 mL/min at ambient temperature (30°C), and 272 nm. The retention time was found to be 1.539 Min and 2.475 Min of Etophylline and Theophyllline was According To International Conference of Harmonization (ICH) Q1A (R2). The method was compared with official BP and other reported methods. The proposed method is economic, simple, and rapid and hence can be employed for routine analysis in quality control laboratories.

Keywords: Linearity plot, Theophylline, Etophylline, ambient temperature, histamine, Coefficient.