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美洛昔康的液相色谱测定及药代动力学

LC determination and pharmacokinetics of meloxicam.

作者信息

Dasandi Bhavesh, Saroj H, Bhat K M

机构信息

Synchron Research Services Pvt. Ltd., Sarkhej Gandhinagar Highway, Bodakdev, 380 054, Ahmedabad, India.

出版信息

J Pharm Biomed Anal. 2002 Jun 1;28(5):999-1004. doi: 10.1016/s0731-7085(02)00064-x.

Abstract

A simple and rapid HPLC assay method for the estimation of meloxicam in plasma was developed. The method totally eliminated the solvent extraction procedure. The plasma proteins were precipitated using perchloric acid (70%) and acetonitrile mixture (1:1 v/v) and the supernatant was directly injected to the HPLC system. The separation was achieved on a Lichrospher C18 5 micron (125x4.0 mm) analytical column with a mobile phase of sodium acetate buffer (pH 3.3, 170 mmol):acetonitrile (62:38 v/v) mixture. Detection was by UV detector at 355 nm. The retention time observed for meloxicam and piroxicam (internal standard) were at 6.0 and 4.0 min, respectively. The response was linear over a range of 50-1500 ng x ml(-1) in human plasma. The method was simple, specific, precise and accurate. The method was also used for the bioequivalence study of meloxicam formulation in healthy, human, Indian, male volunteers.

摘要

建立了一种简单快速的HPLC测定方法用于估算血浆中的美洛昔康。该方法完全省去了溶剂萃取步骤。使用高氯酸(70%)和乙腈混合物(1:1 v/v)沉淀血浆蛋白,上清液直接注入HPLC系统。在Lichrospher C18 5微米(125x4.0毫米)分析柱上进行分离,流动相为醋酸钠缓冲液(pH 3.3,170 mmol):乙腈(62:38 v/v)混合物。通过紫外检测器在355纳米处进行检测。美洛昔康和吡罗昔康(内标)的保留时间分别为6.0分钟和4.0分钟。在人血浆中,响应在50 - 1500纳克×毫升⁻¹范围内呈线性。该方法简单、特异、精密且准确。该方法还用于在健康的印度男性志愿者中进行美洛昔康制剂的生物等效性研究。

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