title: High performance liquid chromatographic method for the determination of cinepazide maleate and its application to a pharmacokinetic study in rats.
abstract: 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 10mM potassium dihydrogen phosphate (pH=4.5):methanol (40:60, v/v), pumped at flow rate of 1.0mL/min, and detected at 303nm. The method exhibited a linear range of 0.12-120μg/mL in blank rat plasma, with the lower detection limit of 0.06μg/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 ±15% from the nominal concentration. The accuracy of cinepazide maleate was within ±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.
authors.affiliation: Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, PR China.
authors.forename: Jinyi
authors.initials: J
authors.lastname: Zhao
authors.affiliation: Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, PR China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Song
authors.affiliation: Department of Clinical Pharmacology, General Hospital of Beijing Military Command of PLA, Beijing 100700, PR China.
authors.forename: Hujun
authors.initials: H
authors.lastname: Wang
authors.affiliation: Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, PR China.
authors.forename: Yuan
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, PR China.
authors.forename: Meiyou
authors.initials: M
authors.lastname: Liu
authors.affiliation: Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, PR China.
authors.forename: Chengtao
authors.initials: C
authors.lastname: Lu
authors.affiliation: Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, PR China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, PR China.
authors.forename: Shan
authors.initials: S
authors.lastname: Wang
authors.affiliation: Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, PR China.
authors.forename: Xiaohe
authors.initials: X
authors.lastname: Zhu
authors.affiliation: Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, PR China.
authors.forename: Wenli
authors.initials: W
authors.lastname: Hai
authors.affiliation: Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, PR China. Electronic address: ad_wen@163.com.
authors.forename: Aidong
authors.initials: A
authors.lastname: Wen
authors.affiliation: Department of Pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032, PR China. Electronic address: 18691555435@163.com.
authors.forename: Yanyan
authors.initials: Y
authors.lastname: Jia
mesh_terms: D000818:Animals; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D057230:Limit of Detection; D016014:Linear Models; D059625:Liquid-Liquid Extraction; D010879:Piperazines / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D051381:Rats; D017207:Rats, Sprague-Dawley; D015203:Reproducibility of Results
chemical_list: D010879:Piperazines; C026896:cinepazide
keywords: Cinepazide maleate; HPLC; Method of validation; Pharmacokinetic