比值光谱导数分光光度法同时测定片剂中扑热息痛和他他他多的含量

S. Bhavin, G. Anuradha
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引用次数: 0

摘要

建立了比值光谱导数分光光度法同时测定复方片剂中扑热息痛(PCM)和他他他多(TAP)含量的方法。分光光度法的方法是基于用二元混合物的吸收光谱除以其中一种化合物的标准光谱得到的比值光谱的一阶导数。TAP和PCM的一阶导数振幅分别在220和232 nm处测定。建立二元混合物中TAP浓度为1 ~ 5 μg mL-1、PCM浓度为6.5 ~ 32.5 μg mL-1的标定图。TAP和PCM的检出限分别为0.098和0.595 μg ml -1, TAP和PCM的定量限分别为0.298和1.805 μg/ml。两种方法的相对标准偏差均小于2%,重复性良好。因此,所提出的方法根据ICH指南进行了验证,并成功地应用于商业片剂中这些药物的测定。
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SIMULTANEOUS DETERMINATION OF PARACETAMOL AND TAPENTADOL IN TABLETS BY RATIO SPECTRA DERIVATIVE SPECTROPHOTOMETRY
The application of the ratio spectra derivative spectrophotometry to the simultaneous determination of Paracetamol (PCM) and Tapentadol (TAP) in combined pharmaceutical tablets is presented. The spectrophotometric procedure is based on the use of the first derivative of the ratio spectra obtained by dividing the absorption spectrum of the binary mixtures by a standard spectrum of one of the compounds. The first derivative amplitudes were measured at 220 and 232 nm for the assay of TAP and PCM, respectively. Calibration graphs were established for 1-5 μg mL-1 for TAP and 6.5-32.5 μg mL-1 for PCM in binary mixture. The detection limits for TAP and PCM were found 0.098 and 0.595 μg mL-1, respectively, while the quantification limits were 0.298 μg mL-1 for TAP and 1.805 μg/ml for PCM. The relative standard deviations were found to be less than 2%, indicating reasonable repeatability of both methods. The proposed methods were hence validated as per ICH guidelines and successfully applied to the determination of these drugs in commercial tablets.
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