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用于解析美索巴莫和对乙酰氨基酚药物混合物的比率光谱的智能操作。

Smart manipulation of ratio spectra for resolving a pharmaceutical mixture of Methocarbamol and Paracetamol.

作者信息

Essam Hebatallah M, Abd-El Rahman Mohamed K

机构信息

Cairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Kasr El-Aini Street, ET 11562 Cairo, Egypt.

Cairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Kasr El-Aini Street, ET 11562 Cairo, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2015 Apr 15;141:1-9. doi: 10.1016/j.saa.2015.01.017. Epub 2015 Jan 21.

Abstract

Two smart, specific, accurate and precise spectrophotometric methods manipulating ratio spectra are developed for simultaneous determination of Methocarbamol (METH) and Paracetamol (PAR) in their combined pharmaceutical formulation without preliminary separation. Method A, is an extended ratio subtraction one (EXRSM) coupled with ratio subtraction method (RSM), which depends on subtraction of the plateau values from the ratio spectrum. Method B is a ratio difference spectrophotometric one (RDM) which measures the difference in amplitudes of ratio spectra between 278 and 286 nm for METH and 247 and 260 nm for PAR. The calibration curves are linear over the concentration range of 10-100 μg mL(-1) and 2-20 μg mL(-1) for METH and PAR, respectively. The specificity of the developed methods was investigated by analyzing different laboratory prepared mixtures of the two drugs. Both methods were applied successfully for the determination of the selected drugs in their combined dosage form. Furthermore, validation was performed according to ICH guidelines; accuracy, precision and repeatability are found to be within the acceptable limits. Statistical studies showed that both methods can be competitively applied in quality control laboratories.

摘要

开发了两种智能、特异、准确且精密的操作比率光谱的分光光度法,用于不经预分离同时测定复方制剂中甲氯芬那酸(METH)和对乙酰氨基酚(PAR)。方法A是一种扩展比率减法(EXRSM)结合比率减法(RSM),它依赖于从比率光谱中减去平台值。方法B是一种比率差分光光度法(RDM),它测量甲氯芬那酸在278和286 nm之间以及对乙酰氨基酚在247和260 nm之间的比率光谱的幅度差。校准曲线在甲氯芬那酸浓度范围为10 - 100 μg mL(-1)和对乙酰氨基酚浓度范围为2 - 20 μg mL(-1)时呈线性。通过分析两种药物不同的实验室制备混合物研究了所开发方法的特异性。两种方法均成功应用于测定复方剂型中所选药物。此外,根据ICH指南进行了验证;发现准确度、精密度和重复性在可接受范围内。统计研究表明,两种方法均可在质量控制实验室中竞争应用。

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