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 µm, 4.6 × 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 1/2β : 6.76 hrs. This method is simple and sensitive HPLC method using UV detector for determination of nicorandil in human plasma.

Selective Determination of Nicorandil with a Single Planar Solid‐state Potentiometric Ion Selective Electrode

“…No trials were done to determine NIC in urine as parent NIC is poorly excreted in urine, while its inactive metabolite (2-nicotinamidoethanol) is the major NIC related compound found in it [29]. On the other hand, C max of NIC (0.14 ug/mL) [30] is beyond the detection limit of the fabricated electrode. Therefore, we are working on improving the sensor sensitivity in plasma.…”

“…Different analytical methods including spectrophotometry [5,6], HPLC [7,8], voltammetry [9], and potentiometry [10] were reported for the determination of NIC. However, the spectrophotometric technique commonly fails in resolving overlapping peaks, and the chromatographic methods are generally time-consuming and utilize hazardous organic solvents.…”