高效液相色谱法测定缬沙坦氢氯噻嗪分散片中两组分含量

目的:建立测定缬沙坦氢氯噻嗪分散片中缬沙坦、氢氯噻嗪含量的高效液相色谱法(high-performance liquid chromatography,HPLC)方法.方法:采用Shimadzu VP-ODS(4.6 mm×250 mm,5μm)色谱柱,以乙腈-0.1％磷酸溶液(用三乙胺调至pH4.0)(47∶53)为流动相,检测波长271 nm,流速1.0 mL/min,柱温25℃,进样量20 μL.结果:缬沙坦在32.05～160.25 μg/mL(y=0.9999)、氢氯噻嗪在5.05～25.25 μg/mL(y=0.9999)的范围内有良好的线性关系,平均回收率分别为98.7％(RSD=1.77％,n=9)、101.4％ (RSD=1.94％,n=9).结论:本方法简便、快速、准确,重复性好,可用于缬沙坦氧氯噻嗪分散片中两组分含量的测定.

Determination of two components in Valsartan and Hydrochlorothiazide Dispersible Tablets by HPLC

Objective：To establish a HPLC method for the determination of two components in Valsartan and Hydrochlorothiazide Dispersible Tablets.Methods：The concentrations were analyzed on the Shimadzu VP-ODS column（4.6 mm×250 mm,5 μm） with the mobile phase consisted of acetonitrile-0.1% phosphoric acid buffer solution（pH 4.0 adjusted by triethylamine）（53：47） at the detection wavelength of 271nm and the injection volume of 20 μL.The flow rate was 1.0 mL/min and the column temperature was 23 ℃.Results：Valsartan and hydrochlorothiazide had good linear relationship in the range of 32.05~160.25 μg/mL and 5.05~25.25 μg/mL.The average recoveries were 98.7%（RSD=1.77%,n=9） and 101.4%（RSD=1.94%,n=9）,respectively.Conclusion：This method is simple,fast and accurate,which can be applied to the concentration determination of Valsartan and Hydrochlorothiazide Dispersible Tablets.