Determination of nifedipine in human plasma by solid-phase extraction and high-performance liquid chromatography: validation and application to pharmacokinetic studies.

Nifedipine, a dihydropyridine calcium channel antagonist, is widely used in the treatment of hypertension and other cardiovascular disorders. A simple, rapid, sensitive, precise and accurate HPLC method, using solid-phase extraction, for the quantitation of nifedipine in human plasma was developed and validated. The calibration graphs were linear in the 5-400 ng/ml concentration range (r>0.999). Recovery for nifedipine was greater than 93.9% and for internal standard nitrendipine was 96.1%. Intra-day and inter-day precision ranged from 1.4 to 4.2 and 3.9 to 5.6%, respectively. Intra-day and inter-day accuracy was ranged from 94.5 to 98.0 and 93.1 to 98.0%, respectively. The method was not interfered with by other plasma components and was applied for the determination of nifedipine in pharmacokinetic study after single oral administration of 10 mg nifedipine to 18 healthy male subjects.