Abstract
A simple assay method for the quality control of appetite suppressant products containing phenylpropanolamine hydrochloride and caffeine has been developed. A methanolic extract of the product was evaporated to dryness and the residue was treated with aqueous solutions of sodium metaperiodate and disodium phosphate. Following addition of methyl p-hydroxybenzoate as internal standard and subsequent filtration, an aliquot of the filtrate was subjected to high-performance liquid chromatography on a 10-μm Partisil ODS-2 column with acetonitrile-water (30:70) as mobile phase. The drug: internal standard peak height ratio at 254 nm was linear over the ranges 0.3–2.0 μg of phenylpropanolamine hydrochloride and 1.1–16.0 μg of caffeine injected. All peaks were well-resolved. The heights equivalent to a theoretical plate (± S.D.) for phenylpropanolamine (as benzaldehyde) and caffeine were ( n 10) 0.42 ± 0.08 and 1.31 ± 0.23 mm, respectively. Overall per cent recoveries (± S.D.) from simulated formulations ( n 6) were 100.7 ± 1.6% phenylpropanolamine hydrochloride and 99.1 ± 1.4% caffeine. The method was applied to marketed products and is also applicable for single dose analysis.
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