反相高效液相色谱法同时测定布洛芬和苯海拉明原料药和制剂含量的新方法的建立与验证

Pavan Kumar, T. Supriya, B. Sivagami, R. Sireesha, R. C. Kumar, M. Babu
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引用次数: 1

摘要

建立了一种简便、准确、快速、精密的同时测定药物剂型中布洛芬和苯海拉明含量的方法。色谱柱为Inertsil ODS (250x4.6mm) 5µ。流动相为乙腈-磷酸盐缓冲液(45:55),流速为1.0 ml/min,检测波长为260 nm。布洛芬和苯海拉明的保留时间分别为2.32 min和2.93 min。采用线性度、精密度(日内、日间% RSD >2)、准确度(98 ~ 102%)、专属性、LOD、LOQ值评价方法的准确性和可靠性。该方法适用于所选复方制剂的常规质量控制分析。
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Development and validation of new analytical method for the simultaneous estimation of ibuprofen and diphenhydramine in bulk and pharmaceutical dosage form by RP-HPLC
A simple, accurate, rapid and precise method was developed for the simultaneous estimation of Ibuprofen and Diphenhydramine in Pharmaceutical dosage form. Chromatogram was run through Inertsil ODS (250x4.6mm) 5µ. Mobile phase used was Acetonitrile and Phosphate buffer (45:55) at a flow rate of 1.0 ml/min and detection wavelength was found to be 260 nm. The retention time was found to be 2.32 min and 2.93 min for Ibuprofen and Diphenhydramine respectively. The accuracy and reliability of the method was assessed by evaluation of linearity, precision (intra-day and inter-day % RSD >2), accuracy (98-102%), specificity, LOD, LOQ values in accordance with ICH guidelines. The developed method is applicable for routine quality control analysis of selected combined dosage forms.
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