HPLC测定缬沙坦片中缬沙坦的含量及有关物质

Determination of Valsartan and Related Substances in Valsartan Tablets by HPLC

目的建立缬沙坦片中缬沙坦的含量测定及有关物质的检测方法。方法采用AgilentPursuitC18色谱柱（4．6mm×250mm，10μm），以乙腈．水一冰醋酸（体积比50：50：0．1）为流动相，检测波长230nm，柱温30℃，流速1．0mL／min，进样量20此。结果缬沙坦在80-320μg／mL（r=0．9998，n=7）范围内与峰面积线性关系良好，高、中、低3个浓度的回收率分别为100．3％，100．3％和100．7％（RSD=1．0％，n=9）。缬沙坦有关物质检查的检测限为0．02μg／mL，且主成分与有关杂质均能有效分离。结论本文建立的含量测定方法快速、准确、重现性好，有关物质检查方法专属、灵敏，可用于缬沙坦片的质量控制。

Objective To establish an HPLC method for determination of valsartan and the related substances in Valsartan Tablets. Methods The HPLC analysis was performed on an Agilent Pursuit C18 （4.6 mm× 250 mm, 10 μm） column. The mobile phase was acetonitrile-water-acetic acid glacial （50：50：0.1） with flow rate of 1.0 mL/min. Thedetection wavelength was 230 nm and the column temperature was 30 ℃. The injection volume was 20 μL. Results The standard curve of valsartan showed good linearity in the range of 80-320 μg/mL （r=0.9998, n=7）. The recovery of valsartan was 100.3 %, 100.3 % and 100.7 % at low, medium and high concentration, respectively （RSD=1.0 %, n=9）. The detection limit of related substances was 0.02 μg/mL and the principal components can be well separated from the impurities. Conclusion The method is quick, accurate and reproducible, which can be used for the quality control of Valsartan Tablets.