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导数分光光度法在复方药物制剂中依那普利、氢氯噻嗪和缬沙坦测定中的应用

Application of derivative spectrophotometry for determination of enalapril, hydrochlorothiazide and walsartan in complex pharmaceutical preparations.

作者信息

Stolarczyk Mariusz, Maślanka Anna, Krzek Jan, Milczarek Joanna

机构信息

Jagiellonian University, Collegium Medicum, Department of Inorganic and Analytical Chemistry, Kraków, Poland.

出版信息

Acta Pol Pharm. 2008 May-Jun;65(3):275-81.

PMID:18646545
Abstract

A derivative spectrophotometry method was developed to determine enalapril, hydrochlorothiazide, candesartan and walsartan in complex antihypertensive drugs. The pharmaceutical preparations containing hydrochlorothiazide and one of the angiotensin convertase inhibitors were investigated. It was found that the developed method enables the constituents of the investigated drugs to be determined directly despite evident interference of the zero order absorption spectra. For determination of enalapril and hydrochlorothiazide as well as candesartan and hydrochlorothiazide the first derivative was used, while for walsartan and hydrochlorothiazide the second derivative was employed. The method was of high sensitivity; the LOD accuracy for enalapril was 2.81 microg x mL(-1), 0.56 microg x mL(-1) for candesartan, 4.02 microg x mL(-1) for walsartan and ranged from 0.31 microg x mL(-1) to 1.78 microgxmL(-1) for hydrochlorothiazide, depending on preparation under investigation. The recovery of individual constituents was within the limit of 100% +/- 5%, RSD varied from 1.11% to 2.94%, and the linearity range was from 4.1 microg x mL(-1) to 20.5 microg x mL(-1) for enalapril, from 6.45 microg x mL(-1) to 32.25 microg x mL(-1) for walsartan, from 2.36 microg x mL(-1) to 11.80 microg x mL(-1) for candesartan, and from 0.96 microg x mL(-1) to 26.00 microg x mL(-1) for hydrochlorothiazide.

摘要

建立了一种导数分光光度法,用于测定复方抗高血压药物中的依那普利、氢氯噻嗪、坎地沙坦和缬沙坦。对含有氢氯噻嗪和一种血管紧张素转换酶抑制剂的药物制剂进行了研究。结果发现,尽管零阶吸收光谱存在明显干扰,但所建立的方法仍能直接测定所研究药物的成分。测定依那普利和氢氯噻嗪以及坎地沙坦和氢氯噻嗪时使用一阶导数,而测定缬沙坦和氢氯噻嗪时使用二阶导数。该方法具有高灵敏度;依那普利的检测限准确度为2.81μg·mL-1,坎地沙坦为0.56μg·mL-1,缬沙坦为4.02μg·mL-1,氢氯噻嗪的检测限准确度根据所研究的制剂在0.31μg·mL-1至1.78μg·mL-1范围内变化。各成分的回收率在100%±5%的范围内,相对标准偏差在1.11%至2.94%之间,依那普利的线性范围为4.1μg·mL-1至20.5μg·mL-1,缬沙坦为6.45μg·mL-1至32.25μg·mL-1,坎地沙坦为2.36μg·mL-1至11.80μg·mL-1,氢氯噻嗪为0.96μg·mL-1至26.00μg·mL-1。

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