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紫外及三种导数分光光度法测定片剂制剂中的依折麦布

UV and Three Derivative Spectrophotometric Methods for Determination of Ezetimibe in Tablet Formulation.

作者信息

Sharma Metreyi, Mhaske Deepali V, Mahadik M, Kadam S S, Dhaneshwar S R

机构信息

Department of Quality Assurance, Bharati Vidyapeeth University Poona College of Pharmacy, Erandwane, Pune-411 038, India.

出版信息

Indian J Pharm Sci. 2008 Mar-Apr;70(2):258-60. doi: 10.4103/0250-474X.41471.

Abstract

UV, first, second and third derivative spectrophotometric methods have been developed for the determination of ezetimibe in pharmaceutical formulation. The solutions of standard and sample were prepared in methanol. For the first method, UV spectrophotometry, the quantitative determination of the drug was carried at 233 nm and the linearity range was found to be 6-16 mug/ml. For the first, second and third derivative spectrophotometric methods the drug was determined at 259.5 nm, 269 nm and 248 nm with the linearity ranges 4-14 mug/ml, 4-14 mug/ml and 4-16 mug/ml. The calibration graphs constructed at their wavelength of determination were found to be linear for UV and derivative spectrophotometric methods. All the proposed methods have been extensively validated. The described methods can be readily utilized for the analysis of pharmaceutical formulation. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations.

摘要

已开发出紫外、一阶、二阶和三阶导数分光光度法用于测定药物制剂中的依折麦布。标准溶液和样品溶液均用甲醇配制。对于第一种方法,即紫外分光光度法,药物的定量测定在233nm波长处进行,线性范围为6 - 16μg/ml。对于一阶、二阶和三阶导数分光光度法,药物分别在259.5nm、269nm和248nm波长处测定,线性范围分别为4 - 14μg/ml、4 - 14μg/ml和4 - 16μg/ml。发现在各自测定波长处构建的校准曲线对于紫外和导数分光光度法均呈线性。所有提出的方法均经过广泛验证。所描述的方法可很容易地用于药物制剂的分析。所提出方法在平均值和标准偏差方面的性能没有显著差异。

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本文引用的文献

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A LC-MS/MS method to quantify the novel cholesterol lowering drug ezetimibe in human serum, urine and feces in healthy subjects genotyped for SLCO1B1.
J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Jan 2;830(1):143-50. doi: 10.1016/j.jchromb.2005.10.034. Epub 2005 Nov 8.
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Liquid chromatography-negative ion electrospray tandem mass spectrometry method for the quantification of ezetimibe in human plasma.
J Pharm Biomed Anal. 2006 Mar 3;40(4):987-92. doi: 10.1016/j.jpba.2005.07.053. Epub 2005 Oct 19.
4
Disposition of the selective cholesterol absorption inhibitor ezetimibe in healthy male subjects.
Drug Metab Dispos. 2002 Apr;30(4):430-7. doi: 10.1124/dmd.30.4.430.

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