摘    要：目的 建立紫外导数光谱法同时测定厄贝沙坦氢氯噻嗪片的含量。方法 以甲醇为溶剂，在210～360 nm波长范围内分别对厄贝沙坦和氢氯噻嗪的标准溶液进行扫描，得到相应的紫外吸收图谱，确定厄贝沙坦的测定波长为245 nm；对氢氯噻嗪的图谱进行求导，氢氯噻嗪的测定波长为270 nm。结果 厄贝沙坦在36~108 mg/L浓度范围内线性关系良好，得到回归方程为A = 0.0353C + 0.0554，相关系数R = 0.9995，精密度试验RSD为0.12%；平均回收率为101.9 %，RSD为0.11 %（n = 9）；稳定性试验表明在90 min内可保持稳定。氢氯噻嗪在3~9mg/L范围内线性关系良好，回归方程为D = 0.0101C + 0.0004，相关系数R = 0.9995，精密度试验RSD为0.71 %；平均回收率为100.3 %，RSD为1.40 %（n = 9）；在120 min内保持稳定。厄贝沙坦的检测限为0.0418 mg/L，氢氯噻嗪的检测限为0 mg/L。结论 本方法操作简单准确、重现性好，可用于厄贝沙坦氢氯噻嗪复合制剂的快速测定。

Abatract

Objective To establish a UV derivative spectrometric method for simultaneous determination of irbesartan hydrochlorothiazide tablets. Methods Using methanol as a solvent, the standard solutions of irbesartan and hydrochlorothiazide were respectively scanned in a wavelength range of 210 to 360 nm to obtain the corresponding ultraviolet absorption spectrum, and the measuring wavelength of irbesartan was 245 nm; got the derivative of the scanning spectrum of hydrochlorothiazide, the measuring wavelength of hydrochlorothiazide was 270 nm.  Results The irbesartan had good linearity in the concentration range of 36~108 mg/L. The regression equation was A = 0.0353C + 0.0554, the correlation coefficient was R = 0.9995, the precision test RSD was 0.12 %, the average recovery was 101.9% and the RSD was 0.11 % (n = 9); the stability test showed that the stability was maintained within 90 minutes. The linear relationship of hydrochlorothiazide was good in the range of 3-9 mg/L, the regression equation was D = 0.0101C + 0.0004, the correlation coefficient was R = 0.9995, The precision test RSD was 0.71 %; the average recovery was 100.3 % and the RSD was 1.40 % (n = 9); it remained stable within 120 minutes. The detection limit of irbesartan was 0.0418 mg/L, and the detection limit of hydrochlorothiazide was 0 mg/L. Conclusion The method is simple, accurate and reproducible. It can be used for rapid determination of irbesartan hydrochlorothiazide.

关键词：厄贝沙坦；氢氯噻嗪；含量测定；导数光谱法

Keyword: irbesartan；hydrochlorothiazide；content determination；UV derivative spectroscopy

目    录

1. 引言 1

1.1 厄贝沙坦 1

1.2 氢氯噻嗪 1

1.3 厄贝沙坦氢氯噻嗪片 2

1.4 紫外可见光分光光度法 3

1.4.1 直接紫外分光光度法 3

1.4.2 导数光谱法 3

1.5 选题依据 4

1.6 实验思路 4

2. 实验部分 5

2.1 仪器、试剂及药品 5

2.1.1 仪器 5

2.1.2 试剂及药品 5

2.2 方法 5

2.2.1 溶剂的选择 5

2.2.2 常用试剂的制备 6

2.2.3 测定波长的选择 6

2.2.4 标准曲线的建立 8

2.3 定量分析方法验证 10

2.3.1 精密度 10

2.3.2 准确度 11

2.3.3 稳定性 12

2.3.4 检测限、定量限 14

2.4 含量测定 14

3. 结论 16

3.1 实验过程分析 16

3.2 实验结果分析 16

参考文献 17

致谢 18

1. 引言

1.1 厄贝沙坦

厄贝沙坦（Irbesartan）的化学名称为2-丁基-3-[4-[2-(1H-四氮唑-5-基）苯基]苯甲基]–1，3-二氮杂螺[4，4]壬-1-烯-4-酮。分子式为C25H28N6O，分子量为428.54，结构式如下图所示：

图1 厄贝沙坦的结构式

厄贝沙坦作为血管紧张素Ⅱ受体拮抗剂，通过阻断血管紧张素Ⅱ受体1与血管紧张素Ⅱ的结合，从而发挥拮抗血管紧张素Ⅱ的一系列作用，使血管扩张，减少醛固酮分泌，减少血容量，最终达到降压的效果[1]。