Abstract

A NEW RP-HPLC METHOD DEVELOPMENTAND VALIDATION OF RP - HPLC METHOD FOR THE ESTIMATION OF IRBESARTAN FROM PHARMACEIICAL DOSAGE FORM

N.Ravindra, *G. Kumaraswamy, B.Jyothsna. M.Bindu, K.B.Pradeesha. Ch.Anjali

Abstract

A simple, precise, rapid and reproducible RP -HPLC method was developed and validated for the determination of Irbesartan in pharmaceutical dosage forms. Chromatography was performed on a Phenomenax LunaC18 (ODS) column (250 mm X 4.6 mm i.d. Particle size 5) water: Acetonitrile in the ratio 50:50 (v/v) as a mobile phase at a flow rate of 1 ml/ min. The detection was carried out at 226 nm using analytical Tech. UV-Visible detector SpD-10AVP. The obtained calibration curve was linear in the concentration range of 10–60g/ ml. The limit of detection and quantification was found to be 0.2645 g/ml and 0.6656 g/ml respectively. It was found that the amount of Irbesartan present in the formulation (IROVEL) was 99.95%. The method was validated statistically using SD, %RSD and SE and the values are found to be within the limits. The recovery studies were performed and the percentage recovery was found to be 99.65 %.

Keywords: Irbesartan, RP-HPLC, UV detection, Isocratic Elution, Development and validation of method in bulk and pharmaceutical formulations.