超高效液相色谱法测定吲达帕胺片中的杂质C

Determination of Impurity C in Indapamide Tablets by UPLC

目的建立测定吲达帕胺片中杂质C的方法。方法采用超高效液相色谱法,色谱柱为ACQUITY UPLC HSS T3 C18(75mm×2.1mm,1.8μm);流动相为缓冲盐-乙腈(70∶30);流速为0.7mL·min^(-1);柱温:40℃;进样量:10μL;采集时间:10min;检测波长:235nm。结果线性范围为0.28~1.67μg·mL^(-1),r=0.9992;杂质C能得到很好的分离,因此采用此法检测本品杂质C能达到要求。结论经方法学验证,本法专属、灵敏、简便,可用于吲达帕胺片中杂质C的测定。

OBJECTIVE To establish a method for the determination of impurity C of Indapamide tab- lets. METHODS The analysis was carried out on a ACQUITY UPLC HSS T3 C18 chromatography column（75mm×2.1mm,1.8μm）. The mobile phase consisted of buff salt and acetonitrile （70： 30） ;The flow rate was 0. 7mL ·min -1 ,the column temperature was 40℃ ,the detection wavelength at 235nm. RESULTS The method of impurity C of Indapamide tablets with a good linear range of 0.28-1.67μg·mL^（-1）,r=0.9992,;The impurity C can be well separated, and the results can meet the requirement. CONCLUSION The established method is sensitive, specific, simple for the determination of the impurity C in Indapamide tablets according to method validation.