缬沙坦氢氯噻嗪片有关物质测定方法研究

Determination of related substances in Valsartan Hydrochlorothiazide Tablets

目的建立加校正因子的主成分自身对照法测定缬沙坦氢氯噻嗪片有关物质。方法采用Agilent Zorbax SB-C18色谱柱,0.1%三氟乙酸溶液为流动相A,乙腈为流动相B,梯度洗脱,检测波长265 nm。结果苯并噻二嗪相关物质A相对于氢氯噻嗪的保留时间为0.9,校正因子为1/3;氢氯噻嗪在0.12～1.49μg.mL-1范围内具有良好的线性关系,r=0.999 9;缬沙坦在0.81～9.72μg.mL-1范围内具有良好的线性关系,r=0.999 9。结论本法简便、可准确地测定缬沙坦氢氯噻嗪片的有关物质。

Objective To establish a main component self - compare with calibration factor method for the determination of the related substances of Valsartan Hydrochlorothiazide Tablets. Methods Agilent Zorbax SB - C18 column was adopted with 0.1% trifluoroacetic acid solution as mobile phase A and acetonitrile as mobile phase B. Gradient elution was used. The detection wavelength was 265 nm. Results Compared with hydrochlorothiazide, the relative retention time of benzothiadiazine related substances A was 0.9, and the calibration factor was 1/3. The linear range of hydrochlorothiazide was 0.12- 1.49 ug . mL- 1, r = 0. 999 9. The linear range of valsartan was 0.81 - 9.72 ug . mL- 1 , r = 0. 999 9. Conclusion This method was convenient, accurate for the determination of related substances in Valsartan Hydrochlorothiazide Tablets.