兔血浆中那格列奈含量测定分析方法的建立与验证
Development and validation of analytical method for the estimation of nateglinide in rabbit plasma.
作者信息
Pani Nihar Ranjan, Nath Lilakant, Singh Akhilesh Vikram, Mahapatra Santosh Kumar
机构信息
Gayatri College of Pharmacy, At-Jamadarpali, Via-Sashan, Sambalpur, Odisha, India.
Department of Pharmaceutical Sciences, Dibrugarh University, Dibrugarh, Assam, India.
出版信息
J Pharm Anal. 2012 Dec;2(6):492-498. doi: 10.1016/j.jpha.2012.05.002. Epub 2012 May 18.
Nateglinide has been widely used in the treatment of type-2 diabetics as an insulin secretogoga. A reliable, rapid, simple and sensitive reversed-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for determination of nateglinide in rabbit plasma. The method was developed on Hypersil BDSC-18 column (250 mm×4.6 mm, 5 mm) using a mobile phase of 10 mM phosphate buffer (pH 2.5) and acetonitrile (35:65, v/v). The elute was monitored with the UV-vis detector at 210 nm with a flow rate of 1 mL/min. Calibration curve was linear over the concentration range of 25-2000 ng/mL. The retention times of nateglinide and internal standard (gliclazide) were 9.608 min and 11.821 min respectively. The developed RP-HPLC method can be successfully applied to the quantitative pharmacokinetic parameters determination of nateglinide in rabbit model.
那格列奈作为一种胰岛素促泌剂已被广泛用于2型糖尿病的治疗。建立了一种可靠、快速、简便且灵敏的反相高效液相色谱（RP-HPLC）法并进行了验证，用于测定兔血浆中的那格列奈。该方法采用Hypersil BDS C-18柱（250 mm×4.6 mm，5 μm），以10 mM磷酸盐缓冲液（pH 2.5）和乙腈（35:65，v/v）为流动相。在210 nm处用紫外-可见检测器监测洗脱液，流速为1 mL/min。校准曲线在25-2000 ng/mL的浓度范围内呈线性。那格列奈和内标（格列齐特）的保留时间分别为9.608 min和11.821 min。所建立的RP-HPLC方法可成功应用于兔模型中那格列奈定量药代动力学参数的测定。
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