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用于测定片剂中氯沙坦钾的一阶导数分光光度法与高效液相色谱法的比较研究。

A comparative study of first-derivative spectrophotometry and high-performance liquid chromatography applied to the determination of losartan potassium in tablets.

作者信息

Ansari Mehdi, Kazemipour Maryam, Khosravi Freshteh, Baradaran Mehdi

机构信息

Department of Pharmaceutics, Faculty of Pharmacy, Kerman Medical Sciences University, Kerman, Iran.

出版信息

Chem Pharm Bull (Tokyo). 2004 Oct;52(10):1166-70. doi: 10.1248/cpb.52.1166.

Abstract

Losartan, a highly effective blood pressure-lowering agent, has been widely used for the treatment of hypertension. A fast and reliable method for the determination of losartan was highly desirable to support formulation screening and quality control. A first-derivative UV spectroscopic method and HPLC were developed for the determination of losartan in the tablet dosage form. The first-derivative spectrum recorded between 220 and 320 nm and a zero-crossing technique for first-derivative measurement at 232.5 nm were selected. The selectivity and sensitivity of the method was in desirable range. In comparison with the direct UV method, first-derivative UV spectroscopy has a definite trough without any interference from UV absorbing-excipients. This method is also fast and economical in comparison with the more time-consuming HPLC method regularly used for formulation screening and quality control and can be used routinely by any laboratory possessing a spectrophotometer with a derivative accessory. The linear concentration ranges were 2-50 microg ml(-1), (D(1)=-0.0159C-0.0056, r=0.9994, n=6). Between-days CV of < or =2.9%, within-day CV of < or =2.1%, and analytical recovery close to 98.1% show the suitability of the method for determination in quality control.

摘要

氯沙坦是一种高效的降压药,已被广泛用于治疗高血压。非常需要一种快速可靠的方法来测定氯沙坦,以支持制剂筛选和质量控制。开发了一种一阶导数紫外光谱法和高效液相色谱法来测定片剂剂型中的氯沙坦。选择在220至320nm之间记录的一阶导数光谱以及在232.5nm处进行一阶导数测量的零交叉技术。该方法的选择性和灵敏度在理想范围内。与直接紫外法相比,一阶导数紫外光谱法有一个确定的波谷,没有来自紫外吸收辅料的任何干扰。与通常用于制剂筛选和质量控制的耗时更长的高效液相色谱法相比,该方法也快速且经济,并且任何拥有带有导数附件的分光光度计的实验室都可以常规使用。线性浓度范围为2 - 50μg ml(-1),(D(1)= - 0.0159C - 0.0056,r = 0.9994,n = 6)。日间变异系数≤2.9%,日内变异系数≤2.1%,分析回收率接近98.1%,表明该方法适用于质量控制测定。

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