Development and Validation of Novel UV Spectroscopy Method for the Estimation of L-Glutathione in Bulk and Formulation with Congo Red

G. Gajeli, S. Kumbhar, G. Patel
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Abstract

A novel UV-Spectroscopy method was developed and validated for the estimation of L-glutathione in bulk and dosage form with congo red. The wavelength at which L-glutathione and congo red mixture product showed maximum absorption at 568nm in distilled water. The developed method range was found to be10-90µg/ml. The developed method validated for linearity, precision, range, limit of detection, the limit of quantification, robustness, specificity, system suitability. The regression equation was found to be y = 0.0045x + 0.121 with correlation coefficient R² = 0.9983. The limit of detection and the quantification limit was 5.05 µg/ml and 15.32 µg/ml respectively. The developed method was found to be linear, precise, robust, economical for the evaluation of L-glutathione in bulk and dosage form.
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新型紫外光谱法测定原料药和刚果红制剂中l -谷胱甘肽含量的建立与验证
建立了用刚果红测定l -谷胱甘肽原料药和剂型的紫外光谱分析方法。l -谷胱甘肽与刚果红混合产物在蒸馏水中的最大吸收波长为568nm。所建立的方法范围为10 ~ 90µg/ml。该方法对线性度、精密度、范围、检出限、定量限、鲁棒性、特异性和系统适用性进行了验证。回归方程为y = 0.0045x + 0.121,相关系数R²= 0.9983。检测限为5.05µg/ml,定量限为15.32µg/ml。该方法线性、准确、可靠、经济,可用于l -谷胱甘肽原料药和剂型的定量评价。
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