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High-performance liquid chromatographic method for the assay of verapamil hydrochloride and related compounds in raw
P M Lacroix1, S J Graham, E G Lovering
1Bureau of Drug Research, Health Protection Branch, Health and Welfare Canada, Tunney's Pasture, Ottawa, Ontario.
Abstract:
A modification of the USP HPLC method [ United States Pharmacopeia XXII, pp. 1444-1446] for the assay of the purity of verapamil hydrochloride has been evaluated for the determination of the drug content and related compounds in drug raw material. The method enables the resolution of 16 related compounds from the parent drug and, in most cases, from each other. The minimum quantifiable amount for most related compounds is less than 0.05%. Six drug raw material samples are analysed and the total impurities found to be 0.3% or less. All drug assay values were within the USP recommended limits of 99.0-100.5%.