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采用反相高效液相色谱法同时测定制剂和人血清中的格列喹酮、非索非那定、布克利嗪和左西替利嗪。

Simultaneous determination of gliquidone, fexofenadine, buclizine, and levocetirizine in dosage formulation and human serum by RP-HPLC.

作者信息

Arayne M Saeed, Sultana Najma, Mirza Agha Zeeshan, Siddiqui Farhan Ahmed

机构信息

Lab 9, Department of Chemistry, University of Karachi, Karachi. 75270, Pakistan.

出版信息

J Chromatogr Sci. 2010 May-Jun;48(5):382-5. doi: 10.1093/chromsci/48.5.382.

Abstract

In the present paper, a simultaneous method has been developed and validated for estimation of gliquidone in the presence of H(1)-receptor antagonists (fexofenadine hydrochloride, buclizine hydrochloride, and levocetirizine dihydrochloride) using reversed-phase high-performance liquid chromatographic technique. A good chromatographic separation between these drugs was achieved using a mobile phase containing methanol-water (80:20 v/v) at pH 3.5 with a flow rate of 1.0 mL/min; and detection was performed at 230 nm with a UV detector. Validation of the method was performed in terms of linearity, accuracy, precision, and limit of detection and quantification. The linearity of the calibration curves for gliquidone, fexofenadine hydrochloride, buclizine hydrochloride, and levocetirizine dihydrochloride were found to be 0.338-50 microg/mL (r = 0.9964), 5-50 microg/mL (r = 0.9956), 0.325-50 microg/mL (r = 0.9967), and 0.553-50 microg/mL (r = 0.9950), respectively. There was no significant difference between the amount of drug spiked in serum and the amount recovered, and serum did not interfere in simultaneous estimation. Thus, the proposed method is suitable for the simultaneous analysis of active ingredients in tablet dosage forms and human serum.

摘要

在本论文中,已开发并验证了一种同时测定格列喹酮的方法,该方法采用反相高效液相色谱技术,可在存在H(1)受体拮抗剂(盐酸非索非那定、盐酸布克利嗪和二盐酸左西替利嗪)的情况下进行。使用含甲醇 - 水(80:20 v/v)、pH 3.5、流速为1.0 mL/min的流动相,实现了这些药物之间良好的色谱分离;使用紫外检测器在230 nm处进行检测。该方法的验证是在线性、准确度、精密度以及检测限和定量限方面进行的。发现格列喹酮、盐酸非索非那定、盐酸布克利嗪和二盐酸左西替利嗪校准曲线的线性分别为0.338 - 50 μg/mL(r = 0.9964)、5 - 50 μg/mL(r = 0.9956)、0.325 - 50 μg/mL(r = 0.9967)和0.553 - 50 μg/mL(r = 0.9950)。血清中添加的药物量与回收量之间无显著差异,并且血清在同时测定中不产生干扰。因此,所提出的方法适用于片剂剂型和人血清中活性成分的同时分析。

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