尼美舒利原料药及其制剂的紫外可见光谱测定方法的建立与验证

R. Xavier Arulappa, M. Jerubin Welsingh, M. Lavanya, T. Sterlin, M. Viji, P. Karuppasamy
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引用次数: 0

摘要

本研究的目的是建立并验证一种简单的紫外光谱法测定尼美舒利的含量。尼美舒利是花生四烯酸合成前列腺素和血小板聚集的抑制剂。它能够通过多种机制(即COX不依赖途径)发挥镇痛和抗炎作用,抑制肿瘤坏死因子(TNFα)和白细胞介素的释放,阻止肥大细胞释放组胺,减少嗜碱性细胞合成血小板活化因子(PAF)。采用系统紫外分光光度计2704 X可见双光束,以溶剂KOH为溶剂进行紫外可见分光光度计分析。检测波长为395nm。根据ICH Q2R1指南,采用准确度、线性度、精密度、稳健性、稳健性、定量限和定量限等参数对方法进行验证。紫外分光光度在5 ~ 25µg/ml范围内呈线性。方法稳定可靠,相对标准偏差小于2。在所有条件下提取率均大于99.19%。结果表明,该方法准确、准确、快速,适用于尼美舒利的常规分析。本研究的目的是建立并验证一种简单的紫外光谱法测定尼美舒利的含量。尼美舒利是花生四烯酸合成前列腺素和血小板聚集的抑制剂。它能够通过多种机制(即COX不依赖途径)发挥镇痛和抗炎作用,抑制肿瘤坏死因子(TNFα)和白细胞介素的释放,阻止肥大细胞释放组胺,减少嗜碱性细胞合成血小板活化因子(PAF)。采用系统紫外分光光度计2704 X可见双光束,以溶剂KOH为溶剂进行紫外可见分光光度计分析。检测波长为395nm。根据ICH Q2R1指南,采用准确度、线性度、精密度、稳健性、稳健性、定量限和定量限等参数对方法进行验证。紫外分光光度在5 ~ 25µg/ml范围内呈线性。方法稳定可靠,相对标准偏差小于2。在所有条件下提取率均大于99.19%。结果表明,该方法准确、准确、快速,适用于尼美舒利的常规分析。
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Development and Validation of UV-Visible spectroscopic method for estimation of Nimesulide in bulk and its pharmaceutical formulation
The aim of the present work was to develop and validate a simple UV Spectroscopic method for the determination of Nimesulide, which is the inhibitor of prostaglandin synthesis from arachidonic acid and platelet aggregation. It has the ability to exert analgesic and anti-inflammatory actions through various mechanisms (ie, COX independent pathways) and also it inhibits the release of tumour necrosis factor (TNFα) and interleukins, and stops the release of histamine from mast cells and reduce the synthesis of platelet activating factor (PAF) from the basophil cells. The UV visible Spectrophotometric analysis was performed using systronics UV-Spectrophotometer 2704 X visible double beam by using solvent KOH. Detection was performed at a wavelength of 395nm. Method validation was carried out according to ICH Q2R1 guidelines by taking the parameters such as accuracy, linearity, precision, ruggedness, and robustness, LOD and LOQ. The UV spectrophotometric was found linear in the range 5- 25µg/ml. The method was rugged and robust with % relative standard deviation less than 2. The extraction recoveries was found to be higher than 99.19% in all experimental conditions. Based upon the performance characteristics, the proposed method was found accurate, precise, rapid and suitable for the determination of nimesulide for routine analysis. The aim of the present work was to develop and validate a simple UV Spectroscopic method for the determination of Nimesulide, which is the inhibitor of prostaglandin synthesis from arachidonic acid and platelet aggregation. It has the ability to exert analgesic and anti-inflammatory actions through various mechanisms (ie, COX independent pathways) and also it inhibits the release of tumour necrosis factor (TNFα) and interleukins, and stops the release of histamine from mast cells and reduce the synthesis of platelet activating factor (PAF) from the basophil cells. The UV visible Spectrophotometric analysis was performed using systronics UV-Spectrophotometer 2704 X visible double beam by using solvent KOH. Detection was performed at a wavelength of 395nm. Method validation was carried out according to ICH Q2R1 guidelines by taking the parameters such as accuracy, linearity, precision, ruggedness, and robustness, LOD and LOQ. The UV spectrophotometric was found linear in the range 5- 25µg/ml. The method was rugged and robust with % relative standard deviation less than 2. The extraction recoveries was found to be higher than 99.19% in all experimental conditions. Based upon the performance characteristics, the proposed method was found accurate, precise, rapid and suitable for the determination of nimesulide for routine analysis.
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