Methodological validation of the dissolution test of valsartan and metolazone tablets / 国际药学研究杂志

ABSTRACT

Objective To establish a method for testing the dissolution of valsartan and metolazone tablets, and validate the method to provide a basis for drug quality control. Methods The dissolution was analyzed by HPLC method. An Agilent SB C18 (4.6 mm×250 mm, 5 μm) column and a mixture of acetonitrile and water were used with the ratio of 50 50 at a flow rate of 1.0 ml/min with UV detection at 235 nm. Results The calibration curve of valsartan and metolazone was 6-120 μg/ml (r=1.0000, n=6) and 37.5-750 ng/ml (r=1.0000, n=6), respectively. The average recovery of the two drugs was 99.85% and 99.44% with RSD of 1.05% and 1.16% (n=9), respectively. The test solution was stable within 24 h and the filter did not interfere with determination as the two drugs were not adsorbed on it. RSD of this method were all less than 2%. Conclusion The method is simple, sensitive, accurate, and with highly distinguished ability for quality control.