Abstract

ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING ASSAY FOR ETOPHYLLINE AND THEOPHYLLINE BY RP-HPLC

Anshu Priya, Jai Shiv Chauhan, Gaurav Pratap Singh Jadaun, Meenakshi Dahiya, D. P. Pathak*

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Abstract

Etophylline and Theophylline Fixed dose combination (FDC) is a combination of two bronchodilator and belongs to methyl xanthine group of drugs. It is used for the treatment of asthma. A simple, accurate, precise, convenient, and validated reverse phase HPLC (RPHPLC) technique has been developed for the assay determination of Etophylline and Theophylline in the parenteral formulation. The determination was carried out using a silica gel column packed with octlysilane, 250 mm × 4.6 mm, i.d., 5 μm particle size and an isocratic mode was adopted for the separation. The mobile phase used for the separation was a mixture of 0.01M Sodium acetate and Methanol (90:10), pH 3.5 and flow rate was 2ml per min. The wavelength chosen for the detection of the drug was 272 nm at ambient temperature and the retention time found was 7.31 min. and 8.33 min. for Theophylline and Etophylline respectively. Recovery values for Theophylline and Etophylline were 98.50-102.90%. The method adopted has shown prominent results as great peak separation, better resolution, linear curve, good % recovery and accurate % RSD values make this method ideal for the determination of Etophylline and Theophylline in the parenteral formulation.

Keywords: Theophylline, Etophylline, RP-HPLC, method development, validation, stability.