零阶导数、一阶导数及曲线下面积紫外分光光度法测定原料药和内服片中酒石酸匹马万色林含量的分析研究

Abdul Wahab, Mohammad Mojeeb Gulzar Khan, A. Shirkhedkar
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摘要

建立简便、快速、灵敏、经济、准确的紫外分光光度法定量测定原料药和内部片剂中酒石酸皮马万色林的含量。本研究旨在根据ICH指南验证开发的方法。酒石酸匹马万色林一种非典型抗精神病药物,也用于治疗帕金森病。采用双光束分光光度计(UV-2450,日本岛津),建立并验证了四种简便的紫外光谱法测定酒石酸皮马万色林。以甲醇为溶剂,在226 nm处观察酒石酸皮马万色林的最大吸光度(?max)。浓度范围5 ~ 30g /ml的校准曲线符合比尔朗伯定律。加样回收率为98 ~ 101%。以% RSD表示的精度值小于2,显示了所开发方法的精确性。统计分析和结果表明,在四种方法中,AUC方法最简单、特异、准确、精密度高。四种方法均可作为原料药和制剂中酒石酸匹马万色林的常规分析方法。关键词:曲线下面积,导数分光光度法,酒石酸皮马万色林,紫外光谱
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Analytical studies on zero order and first order derivative and area under curve UV-spectrophotometric methods for estimation of pimavanserin tartrate in bulk and In-house tablet formulation
The proposed of work to establish simple, rapid, sensitive, economical and accurate UV spectrophotometric methods for the quantificationof Pimavanserin tartrate in bulk material and in-house tablet formulation. This study is designed to validate the developed methods as per ICH guidelines. Pimavanserin tartrate an atypical anti-psychotic drug also used for the treatment of Parkinson Disease. Four simple UV Spectroscopy methods developed and validated for the estimation of Pimavanserin tartrate, by using double beam spectrophotometer (UV-2450, Shimadzu, Japan). Maximum absorbance (?max) of pimavanserin tartrate was observed at 226 nm used methanol as a solvent. The calibration curve of concentration range 5-30 ?g/ml obeyed Beer lambert law. The % recovery was found to be in the range of 98-101%. Precision values observed less than 2 in the terms of % RSD that shows precise nature of developed methods. It was concluded that statistical analysis and the result amongst all four methods, AUC method is most simple, specific, accurate and precise. All four methods can be used as routine analysis of Pimavanserin tartrate in bulk and pharmaceutical formulations. Keywords: Area under curve, Derivative-spectrophotometry, Pimavanserin tartrate, UV Spectroscopy.
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