New validated Ultra High Performance Liquid Chromatographic method for Estimation of Quercetin

IF 0.1 Q4 MEDICINE, RESEARCH & EXPERIMENTAL International Journal of Ayurvedic Medicine Pub Date : 2023-10-03 DOI:10.47552/ijam.v14i3.3710
Mitali Y Kubade, Priya Shetti, Sachin Gudasi
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Abstract

Background: A new Ultra performance liquid chromatographic analytical method was developed and validated for estimation of Quercetin in bulk powder. The reverse phase chromatographic elution using UPLC was carried out in gradient mode on C-18 column (Phenomenex Luna 5 µm, 150 mm X 4.6 mm) as stationary phase utilizing a mobile phase composed of Acetonitrile: 0.1 % formic acid buffer (50:50 v/v) with a flow rate of 1 ml/min and injection volume of 10µl. The analysis was performed at temperature of 400C and detection of eluent was carried out using photo diode array at 371 nm. The newly developed Ultra performance liquid chromatography method was validated in terms of linearity and range, system suitability, specificity, precision, sensitivity, robustness, ruggedness and accuracy as per ICH guidelines. Results: The retention time of quercetin was found to be at 3.9 min with total run time of analysis is 7 minutes. The linearity was observed between the concentration ranges from 0.5 to 16µg/ml with correlation coefficient 0.999. The precision assays values were found to be less than 2% for both the drugs. The Limit of Detection and Limit of Quantification were 0.47µg/ml and 1.44µg/ml for Quercetin. The mean percentage recovery values were found to be within the range of 90-110 %. Conclusion: The proposed method was found to be simple, specific, precise, sensitive, robust, rugged and accurate and can be used for routine quality control analysis of Quercetin.
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超高效液相色谱法测定槲皮素含量的新方法
背景:建立了一种新的超高效液相色谱法测定散装粉末中槲皮素的含量。以C-18色谱柱(Phenomenex Luna 5µm, 150 mm X 4.6 mm)为固定相,流动相为乙腈:0.1%甲酸缓冲液(50:50 v/v),流速为1 ml/min,进样量为10µl,采用UPLC梯度模式进行反相色谱洗脱。分析温度为400℃,洗脱液检测采用光电二极管阵列,波长为371 nm。根据ICH指南,新开发的超高效液相色谱方法在线性和范围、系统适用性、特异性、精密度、灵敏度、稳健性、耐用性和准确性方面进行了验证。结果:槲皮素的保留时间为3.9 min,分析总运行时间为7 min。浓度在0.5 ~ 16µg/ml范围内呈线性关系,相关系数为0.999。两种药物的精密度测定值均小于2%。槲皮素的检出限和定量限分别为0.47µg/ml和1.44µg/ml。平均回收率在90 ~ 110%之间。结论:该方法简便、专属性好、精密度高、灵敏度高、鲁棒性好、坚固耐用、准确度高,可用于槲皮素的常规质量控制分析。
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来源期刊
International Journal of Ayurvedic Medicine
International Journal of Ayurvedic Medicine MEDICINE, RESEARCH & EXPERIMENTAL-
自引率
50.00%
发文量
87
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