稳定性指示常数模式法作为一种新的零阶光谱操作方法,验证了二黄芩苷及其活性代谢物大黄的测定

Aml A. Emam, Nouruddin W. Ali
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引用次数: 7

摘要

提出了一种新的分光光度法——恒吸光度法,用于简单测定以治疗骨关节炎的二乙酰二乙胺和大黄碱为主的碱性降解产物和活性代谢物二乙酰二乙胺为例的二元混合物。该方法具有较高的准确度、精密度、灵敏度、特异性和稳定性。所提出的技术允许测定二黄精和大黄的二元混合物操纵零阶吸收光谱,不需要比例光谱,衍生化步骤,甚至初步分离。利用230和430 nm两个波长之间的恒定吸光度模式在零吸收光谱下测定二乙酰甲醚,而大黄在λmax 430 nm处直接在零阶吸收光谱下测定。所提方法在1 ~ 16 µg mL−1浓度范围内均符合Beer-Lambert定律。根据ICH指南对所建议的方法进行了准确性和精密度的验证。并将所建立的方法应用于不同制剂中二硅黄碱的测定,结果与已有报道的HPLC法进行了统计学比较,其中Student’s t检验和f值无显著差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Validated determination of diacerein and its active metabolite, rhein, by stability indicating constant pattern method as a novel manipulation of zero order spectra

A novel spectrophotometric method named constant absorbance pattern technique was proposed for simple determination of binary mixtures exemplified by diacerein, a treatment of osteoarthritis, and rhein, diacerein main alkaline degradation product and active metabolite. The proposed novel constant absorbance pattern technique was highly accurate, precise, sensitive, specific and stability indicating as well. The proposed technique allowed determination of diacerein and rhein in their binary mixtures manipulating zero order absorption spectra with no need for ratio spectra, derivatization steps, or even preliminary separation. Diacerein was determined at zero absorption spectra depending on the constant absorbance pattern between the two wavelengths 230 and 430 nm while rhein was directly determined at zero order at its λmax, 430 nm. The proposed methods showed obeying for Beer-Lambert’s law in the concentration range of 1–16 µg mL−1 for both diacerein and rhein. Validation of the proposed methods was carried out according to ICH guidelines with respect to accuracy and precision. Moreover, the proposed method was applied for determination of Diacerein in different pharmaceutical formulations and results were statistically compared with those of the reported HPLC one where no significant difference was found concerning Student’s t-test and F-value.

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