High performance liquid chromatographic method for the determination of cinepazide maleate and its application to a pharmacokinetic study in rats

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• 作者：Jinyi Zhao^a ; ¹ ; Ying Song^a ; ¹ ; Hujun Wang^b ; ¹ ; Yuan Sun^a ; ¹ ; Meiyou Liu^a ; Chengtao Lu^a ; Yan Li^a ; Shan Wang^a ; Xiaohe Zhu^a ; Wenli Hai^a ; Aidong Wen^a ; ^{ad_wen@163.com" class="auth_mail} ; Yanyan Jia^a ; ^{18691555435@163.com" class="auth_mail} ; ^{tingfengyusheng@163.com" class="auth_mail}
• 关键词：Cinepazide maleate ; HPLC ; Pharmacokinetic ; Method of validation
• 刊名：Journal of Chromatography B, Analytical Technologies in the Biomedical and Life Sciences
• 出版年：15 April, 2014
• 年：2014
• 卷：957
• 期：Complete
• 页码：105-109
• 全文大小：286 K

文摘

A simple and reliable high performance liquid chromatographic (HPLC) method has been developed and validated to quantify cinepazide maleate, a calcium blocker, in rat plasma. Cinepazide maleate and Tinidazole (internal standard) have been extracted by a simple liquid-liquid extraction before injection into chromatographic system. Chromatographic separation was achieved on a reversed phase C₁₈ column with a mobile phase consisted of a water mixture of 10 mM potassium dihydrogen phosphate (pH = 4.5):methanol (40:60, v/v), pumped at flow rate of 1.0 mL/min, and detected at 303 nm. The method exhibited a linear range of 0.12-120 渭g/mL in blank rat plasma, with the lower detection limit of 0.06 渭g/mL. The method was statistically validated for linearity, accuracy, precision, selectivity and stability following FDA guidelines. The intra- and inter-assay coefficients of variation did not exceed 卤15% from the nominal concentration. The accuracy of cinepazide maleate was within 卤15% of the theoretical value. The assay has been applied successfully in a pharmacokinetic study of cinepazide maleate after a single intravenous at three doses in rat. And cinepazide maleate injection can improve the bioavailability of cinepazide maleate greatly, and has a dose-dependence profile in rats.