Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING REVERSE PHASE HPLC METHOD FOR THE QUANTIFICATION OF VALSARTAN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Himani Tiwari* and Goyal Pradeep

Abstract

Valsartan is an angiotensin-receptor blocker (ARB) that may be used to treat a variety of cardiac conditions including hypertension, diabetic nephropathy and heart failure. A simple, accurate and précised reverse phase high performance liquid chromatographic method was developed for the estimation of Valsartan in bulk and tablet dosage form. An Inertsil ODS-4, 50 mm×4.6mm, 3μm column was used as a stationary phase with a mobile phase A having 1000 ml Water: 1.0 ml TFA and Mobile Phase B having 400 ml water: 600 ml Acetonitrile: 1.5 ml TFA. The flow rate was 1.0 mL/min. The effluent was monitored at 270 nm and eluted at 11.890 min. Calibration curve was plotted with a range from 0.5-3 μg/ml for Valsartan and the correlation was found to be 0.9958. The accuracy range was found between 98-102%. The % RSD values for precision were less than 2.0%. The developed method was validated for the parameters like system suitability, precision, accuracy, and robustness parameters as per ICH guidelines. The proposed method can be useful for the routine analysis of Valsartan in Bulk and pharmaceutical dosage form.

Keywords: Anti-hypertensives, Valsartan, RP-HPLC, Columns, ICH, Validation, Mobile Phase etc.