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Development and validation of an LC method for simultaneous determination of ascorbic acid and three phenolic acids in sustained release tablets at single wavelength

机译:液相色谱法同时测定单波长缓释片中抗坏血酸和三种酚酸的开发和验证

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摘要

A simple, rapid and sensitive column liquid chromatographic method was developed and validated to measure simultaneously the amount of ascorbic acid and phenolic acids at single wavelength (240 nm) in order to assess drug release profiles and drug-excipients compatibility studies for a new sustained release tablet formulation and its subsequent stability studies. A combined isocratic and linear gradient reversed-phase LC method was carried out at 240 nm. Quantification was achieved with reference to the external standards. The linearity for concentrations between 0.042 and 0.150 mg mL(-1) for ascorbic acid, 0.084-0.250 mg mL(-1) for chlorogenic acid, 0.053-0.360 mg mL(-1) for caffeic acid, and 0.016-0.250 mg mL(-1) for ferulic acid (r > 0.99 for all analytes) were established. The recovery of the active ingredients from the samples was at the range of 92.3-102.9%. Intra- and inter-day precisions were less than 2.5%. The limits of detection and quantification were 8 and 24 mu g mL(-1) for ascorbic acid, 18 and 54 mu g mL(-1) for chlorogenic acid, 37 and 112 mu g mL(-1) for caffeic acid, and 11 and 34 mu g mL(-1) for ferulic acid. The determination of the four active ingredients was not interfered by the excipients of the products. Samples were stable in the release mediums (37 degrees C) at least for 12 h.
机译:开发了一种简单,快速,灵敏的柱液相色谱方法,并经过验证可同时测量单波长(240 nm)下抗坏血酸和酚酸的量,以评估新的持续释放的药物释放曲线和药物-赋形剂相容性研究片剂及其后续稳定性研究。在240 nm下进行了等度和线性梯度反相LC的组合方法。参照外部标准进行了定量。抗坏血酸浓度为0.042至0.150 mg mL(-1),绿原酸浓度为0.084-0.250 mg mL(-1),咖啡酸浓度为0.053-0.360 mg mL(-1)和0.016-0.250 mg mL之间呈线性关系建立了阿魏酸(-1)(所有分析物r> 0.99)。从样品中回收的活性成分为92.3-102.9%。日内和日间精度均低于2.5%。检测和定量限为抗坏血酸为8和24μg mL(-1),绿原酸为18和54μgmL(-1),咖啡酸为37和112μgmL(-1)和阿魏酸为11和34μg mL(-1)。四种赋形剂的测定不受产品赋形剂的干扰。样品在释放介质(37摄氏度)中稳定至少12小时。

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