Liquid chromatographic determination of pentaerythritol tetranitrate in pharmaceuticals: collaborative study. 1990

M Carlson
Food and Drug Administration, Minneapolis, MN 55401.

A liquid chromatographic (LC) method for the determination of pentaerythritol tetranitrate (PETN) in pharmaceutical formulations and the bulk drug triturate was evaluated in an interlaboratory study that included 12 participating laboratories. The procedure involves extraction of the active ingredient with mobile phase, followed by filtration of the extract and reverse-phase liquid chromatography using an octadecylsiliane bonded phase column and UV detection at 230 nm. The mobile phase composition is 35% water in acetonitrile (v/v). Three bulk drug samples (20, 20, and 35% PETN), 2 commercial tablet formulations (20 and 80 mg PETN/tablet), and 1 commercial capsule formulation (45 mg PETN/capsule) were analyzed in duplicate by the proposed method. Repeatability (sr, RSDr) and reproducibility (SR, RSDR) based on peak height measurement for these samples ranged from 0.0066 to 0.1806 (0.53-3.36%) and 0.0165 to 0.2075 (0.76-3.86%), respectively. Results for peak area measurements ranged from 0.0145 to 0.2011 (0.93-3.74%) and 0.0231 to 0.2091 (1.28-3.89%), respectively. The method has been approved interim official first action by AOAC.

UI MeSH Term Description Entries
D010417 Pentaerythritol Tetranitrate A vasodilator with general properties similar to NITROGLYCERIN but with a more prolonged duration of action. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1025) Dilcoran,Erinit,Nirason,Nitrodex,Pentalog,Peritrate,Tetrate,Tetranitrate, Pentaerythritol
D002214 Capsules Hard or soft soluble containers used for the oral administration of medicine. Capsule,Microcapsule,Microcapsules
D002853 Chromatography, Liquid Chromatographic techniques in which the mobile phase is a liquid. Liquid Chromatography
D005374 Filtration A process of separating particulate matter from a fluid, such as air or a liquid, by passing the fluid carrier through a medium that will not pass the particulates. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed) Filtrations
D013056 Spectrophotometry, Ultraviolet Determination of the spectra of ultraviolet absorption by specific molecules in gases or liquids, for example Cl2, SO2, NO2, CS2, ozone, mercury vapor, and various unsaturated compounds. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed) Ultraviolet Spectrophotometry
D013607 Tablets Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed) Tablet

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