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Abstract
A stability indicating reversed phase high-performance liquid chromatographic assay of propranolol (PP) was developed. The assay enabled the quantitation of PP in both diffusate and human skin extract samples of permeation study, at as low as 0.1 μg/ml with a signal noise ratio of 7. Baseline resolution of PP from internal standard, Verapamil (VRP) and degraded products was achieved with a cyano column and a mobile phase of 47% acetonitrile in water with 5 mM heptane sulfonic acid as the ion pairing agent. The linear range was established at 0.5–10 μg/ml, and 1–15 μg/ml, for diffusate and skin extract samples, respectively. The assay was reproducible with low within-day (2.2 and 8.8 % for diffusate and skin extract, respectively) and between-day (2.2 and 7.7%, respectively) variations. The applicability of the assay for transdermal permeation studies of PPHC1 and PP was demonstrated.