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目的建立缬沙坦聚乙二醇6000(PEG 6000)固体分散体中缬沙坦含量测定的反相高效液相法(RP-HPLC)。方法以PEG6000为水溶性载体,泊洛沙姆188(F68)为表面活性剂,采用冷冻干燥法制备缬沙坦固体分散体。以乙腈水醋酸(60∶40∶0.1)为流动相,采用RP-HPLC法测定固体分散体中缬纱坦的含量。结果缬沙坦与辅料及溶剂峰分离良好,缬沙坦在1.0～50.0μg/ml质量浓度范围内与峰面积成良好的线性关系(r=0.999 9,n=6),日内精密度试验的相对标准偏差(RSD)为0.55%～1.36%(n=5),日间精密度试验的RSD为0.54%～1.50%(n=5),回收率为99.68%～101.00%(n=5)。结论该方法简便、易行,可用于缬沙坦-PEG6000固体分散体中缬沙坦的含量测定。
Objective To establish an RP-HPLC method for the determination of valsartan in solid dispersion of polyethylene glycol 6000 (PEG 6000). Methods PEG6000 as a water-soluble carrier, poloxamer 188 (F68) as a surfactant, was prepared by freeze-drying valsartan solid dispersion. Acetonitrile-water-acetic acid (60:40:0.1) as mobile phase, RP-HPLC method was used to determine the content of Valerian Tan solid dispersion. Results Valsartan was well separated from the excipients and solvent peaks. Valsartan had a good linear relationship with the peak area (r = 0.999 9, n = 6) within the range of 1.0 ~ 50.0 μg / ml. Intravenous precision test The relative standard deviations (RSDs) ranged from 0.55% to 1.36% (n = 5). The RSDs during daytime precision tests ranged from 0.54% to 1.50% (n = 5) and the recoveries ranged from 99.68% to 101.00% . Conclusion The method is simple and easy to use and can be used for the determination of valsartan in valsartan-PEG6000 solid dispersion.