固体分散体中缬沙坦的含量测定

Content Determination of Valsartan in Solid Dispersion

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 determination of drug content in valsartan-polyethylene glycol 6000（PEG6000） solid dispersion.Methods Valsartan solid dispersion was prepared by a lyophilization method with PEG 6000 as hydrophilic carrier,with poloxamer 188（F68） as a surfactant.HPLC analysis was performed for determination of drug content in valsartan-PEG6000 solid dispersion with mobile phase of acetonitrile-water-acetic acid（60∶40∶0.1）.Results It had a good linear relation in the range of 1.0-50.0 μg/ml（r=0.9999,n=6）.The intra-day precision（RSD） was from 0.55% to 1.36%（n=5）,the inter-day precision（RSD） was from 0.54% to 1.50%（n=5） and the recovery rate was from 99.68% to 101.00%（n=5）.The drug content in solid dispersion was（97.26±1.12）%.Conclusion The developed method is simple,accurate and reliable for determination of drug content in valsartan-PEG6000 solid dispersion.