Mandal U, Ganesan M, Jayakumar M, Pal T K, Chattaraj T K, Ray Krishnangshu, Banerjee S N
Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata 700032.
J Indian Med Assoc. 2003 Aug;101(8):486-8.
A convenient, sensitive and simple method for the determination of rofecoxib in human plasma is presented. The analytical technique is based on reversed phase high performance liquid chromatography coupled with UV detector (Knauer, Germany) set at 272 nm. The retention time of rofecoxib after recovery from plasma, was 8.9 minutes. The method has been validated over a linear range of 50-450 ng/ml from plasma. After validation the method was used to study the pharmacokinetic profile of rofecoxib in 6 healthy volunteers as per DCGI guidelines after administration of a single oral dose (50 mg). The extraction efficiency from plasma varied from 93.95-99.58%. The minimum quantifiable concentration was set at 50 ng/ml (% CV < 10%). The pharmacokinetic parameters were Cmax = 318.58 +/- 30.65 ng/ml at tmax = 2.66 +/- 0.25 hours, AUC0-t = 4007.88 +/- 438.32 ng hour/ml, AUC0-yen = 5454.66 +/- 822.29 ng hour/ml, Kel = 0.0433 +/- 0.0067/hour, and t1/2 = 16.36 +/- 2.89 hours.
本文提出了一种简便、灵敏且简单的测定人血浆中罗非昔布的方法。该分析技术基于反相高效液相色谱法，并与设定在272nm的紫外检测器（德国Knauer公司）联用。从血浆中回收后，罗非昔布的保留时间为8.9分钟。该方法在血浆50 - 450 ng/ml的线性范围内得到了验证。验证后，按照药品临床试验管理规范指南，该方法被用于研究6名健康志愿者单次口服剂量（50mg）后罗非昔布的药代动力学特征。血浆提取效率在93.95% - 99.58%之间。最低可定量浓度设定为50 ng/ml（变异系数% CV < 10%）。药代动力学参数为：在tmax = 2.66 ± 0.25小时时，Cmax = 318.58 ± 30.65 ng/ml；AUC0 - t = 4007.88 ± 438.32 ng·小时/ml；AUC0 - ∞ = 5454.66 ± 822.29 ng·小时/ml；Kel = 0.0433 ± 0.0067/小时；t1/2 = 16.36 ± 2.89小时。
