Comparison of Analytical Spectrophotometric Methods for the Determination of Tetrabenazine in Tablets

K. P. Kumar, C. Swetha, J. Tejaswini, V. P. K. Reddy, D. Subramanyam, Chinnagollareddy Rupavani, Kothuru Renuka
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Abstract

Background: Tetrabenazine was approved in the year of 2008 by USFDA. It was indicated mainly as an antipsychotic drug but now-a-days it is used for the treatment of hyperkinetic disorders. Objective: The objective of the study was to develop a simple and cost-effective spectrophotometric methods for the determination of tetrabenazine in tablets. Materials and Methods: The UV-Visible spectrophotometric studies carried out by Shimadzu UV 1800 with UV probe software and FT-IR studies using bruker alpha with opus software. The UV spectrum at 284 nm (Method A) and visible spectrum at 454 nm (Method B) are recorded. The FT-IR band of carbonyl group in tetrabenazine appeared at 1700 cm−1 with two-point baseline between 1650-1750 cm−1 (Method C). Results: Method A: The UV method was proved linear over the range of 10–50 μg/mL with correlation coefficient r2=0.9988 and mean recovery of 99.02% to 101.54%. Method B: The colorimetric method involves oxidative reaction of tetrabenazine and it yields green color chromogen. The linear concentrations over the range of 3-15 μg/mL with correlation coefficient of r2=0.9981 and mean recovery of 99.93% to 100.50%. Method C: The FT-IR method was showed linear over the range of 5-25 μg/mg, with correlation coefficient r2=0.9998 and mean recovery of 100.75% to 100.91%. The results of tetrabenazine tablets showed good agreement with their label claim. The results of ANOVA declare there was no significant difference between these spectrophotometric methods. Conclusion: Hence, these spectroscopic methods can be used for routine quality testing analysis of tetrabenazine in pharmaceutical laboratories.
分析分光光度法测定片剂中丁苯那嗪含量的比较
背景:Tetrabenazine于2008年获得美国fda批准。它主要被认为是一种抗精神病药物,但现在它被用于治疗多动障碍。目的:建立一种简便、高效的分光光度法测定片中丁苯那嗪含量的方法。材料与方法:紫外可见分光光度法采用岛津UV 1800,紫外探针软件;傅里叶红外光谱法采用bruker alpha, opus软件。记录284 nm的紫外光谱(方法A)和454nm的可见光谱(方法B)。丁苯那嗪中羰基的红外光谱出现在1700 cm−1处,两点基线在1650 ~ 1750 cm−1之间(方法C)。结果:方法A:紫外法在10 ~ 50 μg/mL范围内线性良好,相关系数r2=0.9988,平均回收率为99.02% ~ 101.54%。方法二:比色法采用丁苯那嗪氧化反应生成绿色显色剂。浓度在3 ~ 15 μg/mL范围内呈线性关系,相关系数r2=0.9981,平均回收率为99.93% ~ 100.50%。方法C:红外光谱法在5 ~ 25 μg/mg范围内线性良好,相关系数r2=0.9998,平均加样回收率为100.75% ~ 100.91%。丁苯那嗪片的检测结果与标签上的要求相符。方差分析的结果表明,这些分光光度法之间没有显著差异。结论:该方法可用于药物实验室的常规质量检测分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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