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用于分析含硝酸甘油、硝酸异山梨酯或季戊四醇四硝酸酯的缓释制剂的高效液相色谱法的验证

Validation of high-performance liquid chromatographic methods for analysis of sustained-release preparations containing nitroglycerin, isosorbide dinitrate, or pentaerythritol tetranitrate.

作者信息

Gelber L, Papas A N

出版信息

J Pharm Sci. 1983 Feb;72(2):124-6. doi: 10.1002/jps.2600720207.

Abstract

The assay of sustained-release tablets or capsules containing nitroglycerin, isosorbide dinitrate, or pentaerythritol tetranitrate by high-performance liquid chromatography is described. Acetonitrile was found to be the sample preparation solvent with the most general applicability to these products. Anisole was used as an internal standard for nitroglycerin and pentaerythritol tetranitrate, while 4-chloroacetanilide was used for isosorbide dinitrate. The method, which uses a C18 bonded-phase column, a methanol-water mobile phase, and 214-nm detection, was shown to be accurate, linear, and reproducible.

摘要

描述了采用高效液相色谱法测定含硝酸甘油、二硝酸异山梨酯或季戊四醇四硝酸酯的缓释片剂或胶囊。发现乙腈是对这些产品适用性最广的样品制备溶剂。苯甲醚用作硝酸甘油和季戊四醇四硝酸酯的内标,而4-氯乙酰苯胺用于二硝酸异山梨酯。该方法使用C18键合相柱、甲醇-水流动相和214nm检测,结果表明该方法准确、线性且可重现。

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