Determination of Isosorbide Dinitrate in Serum by Gas Chromatography with New Generation of Electron Capture Detector and its Application in Pharmacokinetic Study

Abstract

Isosorbide dinitrate (ISDN) is an effective drug in treatment of angina pectoris. In this study a new generation of electron capture detector (non-radioactive) with a short, non-polar and wide-bore column was used for analysis of ISDN in human serum. ISDN was extracted from serum by a mixture of ether and ethyl acetate and concentrated at room temperature. The method was linear between 5-50 ng/mL. Recovery and accuracy were 99-108% and greater than 90%, respectively, and inter-day precision was lower than 13%. Pharmacokinetic parameters were analyzed after oral administrations of Isocor 40 mg sustained release tablet in comparison with Isoket Retard 40. The statistical results obtained from comparison of Cmax, Tmax and AUC ???????????????????????????????????? ?????? ???????????????????????????????????????????????????????????????????????????????? ???????????????????????????????????????????????????????? were reported to be bioequivalent. Further more, the method used was found to be sensitive and accurate in pharmacokinetic studies.