q -吸收比分光光度法同时测定利福平及其生物增强剂含量的建立与验证3、5‘-DIHYDROXYFLAVONE-7-O-B-D-GALACTURONIDE-4 -O-B-D-GLUCOPYRANOSIDE;散装和配方

S. Bhusari, S. Waghmare, P. Wakte
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引用次数: 2

摘要

本研究展示了利福平(Rifampicin, RIF)及其生物增强剂同时测定的分析方法的发展;3 ',5二羟黄酮-7-O-β- d -半乳糖醛酸-4 ' -O-β- d -葡萄糖吡喃苷(CC-I)的联合剂型,采用q -吸光度比概念。在方法开发过程中,使用了两个不同的波长,一个代表等吸收点(370 nm),另一个代表利福平的λmax (239 nm)。在甲醇与水的比例为80:20 v/v的溶剂体系中反应最佳。在利福平2 ~ 20 μg/ml和cc - 1 1 ~ 24 μg/ml的浓度范围内,紫外分光光度法与利福平呈线性关系。通过加标后的回收率研究,发现该方法对RIF和cc - 1的准确度分别在99.94 ~ 100.30和99.90 ~ 99.96%之间。以相对标准偏差%计算,RIF和cc - 1的日内精密度分别在0.21 ~ 1.36和0.21 ~ 1.77之间。RIF和cc - 1的日间精度范围分别在0.13 ~ 1.94和0.11 ~ 1.58之间。该方法对RIF的定量限和定量限分别为0.043和0.014 μg/ml,对cc - 1的定量限分别为0.37和0.12 μg/ml。该方法具有鲁棒性和坚固性。该方法成功地用于由原料药和常用辅料组成的制剂中RIF和CC-I含量的估算。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
DEVELOPMENT AND VALIDATION OF Q-ABSORBANCE RATIO SPECTROPHOTOMETRIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF RIFAMPICIN AND ITS BIOENHANCER; 3, 5'-DIHYDROXYFLAVONE-7-O-B-D-GALACTURONIDE-4'-O-B-D-GLUCOPYRANOSIDE; IN BULK AND FORMULATION
The present research work demonstrates an analytical method development for simultaneous estimation of Rifampicin (RIF) and its bioenhancer; 3’,5dihydroxyflavone-7-O-β-D-galacturonide-4’-O-β-D-glucopyranoside (CC-I) in combined dosage form using Q-absorbance ratio concept. While method development, two different wavelengths one representing Iso-absorptive point (370 nm) and other representing the λmax of Rifampicin (239 nm) were used. Optimum response was obtained in solvent system that comprises methanol and water in ratio of 80:20 v/v. Proposed UV method was found to be linear over the concentration range of 2-20 μg/ml for Rifampicin and that of 1-24 μg/ml for CC-I. On the basis of recovery studies after standard addition, accuracy of proposed method was found to be in between 99.94 to 100.30 and 99.90 to 99.96 % for RIF and CC-I respectively. Intra-day precision of the method in terms of % relative standard deviation was found to be in between 0.21 to 1.36 and 0.21 to 1.77 for RIF and CC-I respectively. Inter-day precision range of the method for RIF and CC-I was found to be in between 0.13 to 1.94 and 0.11 to 1.58 respectively. LOD and LOQ of proposed UV method were 0.043 and 0.014 μg/ml for RIF and 0.37 and 0.12 μg/ml for CC-I. Proposed UV method was robust and rugged in nature. Proposed method was successfully used for the estimation of RIF and CC-I contents of in-house formulation consisting of APIs and the common excipients.
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