1H-NMR assay of papaverine hydrochloride and formulations

A precise and specific 1H-NMR method has been developed for the assay of papaverine hydrochloride (1) as a bulk drug, as well as in tablet and injection dosage forms. The assay depends upon the integration of the 12 protons of the four methoxy groups of 1 relative to that of the three methyl protons of acetanilide (internal standard). In addition to the accurate quantitative determination of 1, the method provides a specific means of identifying 1 as well as detecting other alkaloids or impurities.