SENSITIVE HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC ASSAY FOR NIFEDIPINE IN HUMAN PLASMA UTILIZING ULTRAVIOLET DETECTION

A rapid, simple, sensitive and selective reversed-phase high-performance liquid chromatographic (HPLC) technique is reported for the determination of nifedipine in human plasma. The procedure involves extraction of nifedipine from plasma under alkaline conditions (pH 12), separation via reversed-phase HPLC and ultraviolet detection (350 nm). The peak corresponding to nifedipine was free of interference from its photodegradation products or metabolites. The method was validated over the range 5-250 ng/ml nifedipine using weighted least-squares linear regression analysis. Accuracy and precision were within approximately 10% or less over the concentration range, except for the lowest concentration point which, nonetheless, was acceptable and approached 15%. The minimum quantifiable concentration of nifedipine was determined to be 5 ng/ml. The minimum detectable concentration was in the order of 1 ng/ml. Analysis of plasma samples collected from healthy volunteers demonstrate that this assay is applicable to clinical and pharmacokinetic studies.