【摘要】 目的建立HPLC法测定缬沙坦氢氯噻嗪分散片中缬沙坦和氢氯噻嗪有关物质的方法。方法 C18柱(250 mm×4.6mm,5μm);流动相A为0.1%磷酸,B为乙腈,梯度洗脱:0~10 min,A:80%→50%;10~35 min,A:50%→50%;35~40 min,A:50%→80%;40~50 min,A:80%→80%;流速1.0 mL/min;检测波长265 nm。结果缬沙坦峰与氢氯噻嗪峰,与各杂质峰均能良好分离。结论该方法简便、灵敏、专属性好,可用于缬沙坦氢氯噻嗪分散片有关物质的检查。更多还原

【Abstract】 Objective To establish a HPLC gradient elution method for the determination of related substances in Valsartan and Hydrochlorothiazide Dispersible Tablets.Methods The separation was performed on a C18 column(250mm×4.6mm,5 μm).With mobile phase A of 0.1% phosphate and mobile phase B of acetonitrile,a gradient elution was performed as followed:0-10 min,A:80%→50%;10-35 min,A:50%→50%;35-40 min,A:50%→80%;40-50 min,A:80%→80%.The flow rate was 1.0ml/min and the detection wavelength was 265nm.Results Good chromatographic separation among valsartan peak,hydrochlorothiazide peak and impurities peaks were obtained.Conclusion The method is simple,sensitive and special,and it is suitable for the determination of the related substances of Valsartan and Hydrochlorothiazide Dispersible Tablets.更多还原