A Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Valsartan and Clinidipine Combined Tablet dosage forms
The Present Research study was developed as simple, accurate and precise isocratic RP-HPLC method has been developed and validated for simultaneous determination of Clinidipine and Valsartan in tablets. The chromatographic separation was carried out on an cosmosil packed column (250×4.6,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 Clinidipine and Valsartan 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 Clinidipine and Valsartan in bulk drug and tablet dosage form.
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