تعيين خلوص شيميايي كلوزاپين C] 14[ به روش كروماتوگرافي مايع با كارايي بالا

Determination of Chemical Purity of [14C] Clozapine, Using HPLC Method.

The mechanism of action and metabolism of clozapine which is considered as a complicated drug used in psychopharmacology, is not completely understood. The effects of this compound in human body are related to some interactions of this compound with serotonin and dopamine neurotransmitter receptors. To further elucidate the mechanism of action and to support the ongoing drug metabolism studies, [I4C] clozapine with a suitable radiochemical purity was synthesized in the Nuclear Science Research School of the AEOI. In this report, the radiochemical and chemical purity of [14C] clozapine were determined by the liquid scintillation and the reversed phase-HPLC, respectively. Separation of [14C] clozapine and its synthesized interface products were carried out using a C8 optimal column and a UV detector at 254nm. The mobile phase consisted of acetonitril- buffered aqueous solution of sodium phosphate with a flow rate of lml/min. The detection limit and the analytical precision of RP-HPLC method were 0.1 ng and 1-3.4%, respectively. The chemical purity of the synthesized clozapine was >99%. For determination of the activity and the radiochemical purity, a liquid scintillation spectrometer was used and the counting was made by direct addition of samples to ACS (Amersham) solution. The specific activity of the synthesized clozapine was 1 (mu)Ci/mg and the radiochemical purity higher than 99% was obtained.