Stability indicating RP-HPLC method for the estimation of Valsartan in pharmaceutical dosage form

Abstract

–A simple, specific, accurate, precise and stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method is developed for estimation of Valsartan in tablet dosage form. The method employed, Phenomenox C18, 5µm,25cm x 4.6 mm i.d. column in isocratic mode, with mobile phase of methanol & phosphate buffer pH 3.0 in ratio of 65:35(v/v) . The flow rate was 1mL min-1 and effluent was monitored at 210 nm. Retention time was found to be 6.22 min. The method was validated in terms of Linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 10- 100 µg/ml respectively. The LOD and LOQ values for HPLC method were found to be 0.02 and 0.06 µg/ml respectively. No chromatographic interference from tablet excipients was found. The proposed method was successfully used for estimation of Valsartan in tablet dosage form. Keywords––Valsartan,