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Development of an RPLC-based Method for Measurement of Indoprofen Stability and Validation of the Method
作者姓名:刘怡伯  陈福安  李仁爱  何秀娥  吴安邦
作者单位:[1]College of Pharmacy, Taipei Medical University, Taipei 11031, Taiwan [2]Department of Pharmacy, Tajen Institute of Technology, Pingtung 90703, Taiwan
摘    要:A method for quantitative measurement of the photochemical decomposition of the anti-inflammatory agent, indoprofen (INP) is descriped. An RPLC-based assay that could determine the extent of degradation of INP in a rapid, sensitive, and accurate manner was developed. The method was validated under photoirradiation. Quantitation was monitored with an Inertsil ODS-3V column using a mobile phase of acetonitril and 1% HOAc solution in deionized H2O. Statistics relevant to the system criteria, peak integrity and resolution among the parent drug and its degradation products were performed. From the intra- and inter-day tests, the coefficients of variation were found to range from 0.59% to 4.25% for the former and from 0.71% to 4.86% for the latter. The good selectivity and specificity of this RPLC-based procedure render it suitable for measurements of INP stability.

关 键 词:吲哚洛芬  光降解  测量  稳定性  RPLC方法  抗炎药物
收稿时间:2006-03-20
修稿时间:2006-03-202006-06-08

Development of an RPLC-based Method for Measurement of Indoprofen Stability and Validation of the Method
LIOU, Yi-Bo, CHEN, Fu-An, LEE, Jen-Ai, HO, Hsiu-O, WU, An-Bang.Development of an RPLC-based Method for Measurement of Indoprofen Stability and Validation of the Method[J].Chinese Journal of Chemistry,2006,24(11):1570-1574.
Authors:LIOU  Yi-Bo  CHEN  Fu-An  LEE  Jen-Ai  HO  Hsiu-O  WU  An-Bang
Institution:a College of Pharmacy, Taipei Medical University, Taipei 11031, Taiwan; b Department of Pharmacy, Tajen Institute of Technology, Pingtung 90703, Taiwan
Abstract:A method for quantitative measurement of the photochemical decomposition of the anti‐inflammatory agent, indoprofen (INP) is descriped. An RPLC‐based assay that could determine the extent of degradation of INP in a rapid, sensitive, and accurate manner was developed. The method was validated under photoirradiation. Quantitation was monitored with an Inertsil ODS‐3V column using a mobile phase of acetonitril and 1% HOAc solution in deionized H2O. Statistics relevant to the system criteria, peak integrity and resolution among the parent drug and its degradation products were performed. From the intra‐ and inter‐day tests, the coefficients of variation were found to range from 0.59% to 4.25% for the former and from 0.71% to 4.86% for the latter. The good selectivity and specificity of this RPLC‐based procedure render it suitable for measurements of INP stability.
Keywords:indoprofen  photodegradation  quantitation
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