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

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.