A Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Valsartan and Clinidipine Combined Tablet dosage forms

Abstract

The Present Research study was developed as simple, accurate and precise stability indicating RP-HPLC method has been developed and validated for simultaneous determination of Valsartan and Clinidipine in tablet dosage forms. The chromatographic separation was carried out on an Waters column (150×4.6,i.d 5µ ) with a mixture of Acetonitrile : phosphate buffer pH 3.5 adjusted with orthophosphoric acid (70:30, v/v) as mobile phase; at a flow rate of 1.0 ml/min. UV detection was performed at 254 nm. The retention times were 2.33 and 3.55 min. for Valsartan and Clinidipine respectively. Calibration plots were linear (r²>0.998) over the concentration range 1.2-6 μg/ml for Clinidipine and 10-50 μg/ml Valsartan. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Valsartan and Clinidipine    in   tablet dosage form.