HPLC method for the determination of nicorandil in human plasma

Abstract

The present study is to determine of sensitive nicorandil analysis method using HPLC and measure the pharmacokinetics parameters (bioavailability, C(max), T(max), Ke, T(1/2)) of nicorandil (5 mg, Tab; Choongwae Pharma Corporation). Plasma (500 ul) was mixed with furosemide (internal standard, 500 ug/ml). Detection wavelength was 256 nm. The mixture of 0.01 M ammonium acetate and acetonitrile 80:20 (v/v) was used mobile phase. The HPLC separation was accomplished on ODC reverse HPLC column. The nicorandil was analyzed by a HPLC system, which consists of CAPCELL PAK C18 column (5 mu m, 4.6 x 150 mm) and a chromatography data analysis S/W, using a isocratic mobile phase (mixture of 0.01 M ammonium acetate and acetonitrile 80:20 < v/v >) at 1.0 ml/min. Its sensitivity selectivity, accuracy and precision must be adequate for the bioavailabilty study of nicorandil, and the linearity (r(2) >= 0.9994) of nicorandil was also proved in the range of 0.05 ug/ml - 3 ug/ml. The pharmacokinetic parameters of nicorandil (5 mg) tablets were measured as the follow. AUC: 0.19 ug/ml-hr, C(max): 0.14 ug/ml, t(max): 0.58 hr, Ke: 0.11 hr(-), t(1/2 beta): 6.76 hrs. This method is simple and sensitive HPLC method using UV detector for determination of nicorandil in human plasma.