| Objective: To establish a quality criteria to control the quality of ranolazine raw material and to study pharmacokinetic profile of ranolazine in Sprague-Dawley rats.Methods: According to the methods of Chinese Pharmacopoeia, used IR, UV, HPLC, and GC to test the physico-chemical property of ranolazine such as appearance, melting point, solubility, purity et al. Established a RP-HPLC method to determine the content and related substances of ranolazine and a headspace gas chromatography method to determine the residual organic volatile solvents in ranolazine raw material. A HPLC method was used to determine ranolzaine in rats before and at different time after intragastric administrated different doses of ranolazine. Some pharmacokinetic parameters and concentration-time curve were offered. Rats of ranplazine group (n = 6 ) were treated daily for 5 d with ranolazine (50 mg· kg-1 ),ControI animals(n = 6) were treated with aqueous PEG400. the liver microsomes of rats were distilled by different velocity centrifugation. An UV method was used to measure total cytochrome P450 contents in liver microsomes, and the activities of some CYP450 of rats were measured by spectrophotometer.Results: On chromatographic condition of removing interference of degradation products and midbodies, the content of related substances in ranolzaine was less than 1%; The method was linear within the range of 0.102～2.034 mgmL-1(r = 0.9999).
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