用紫外可见分光光度法同时估计片剂在其组合中的标签要求

D YelekarP, Chaudhari S.B, D ChourasiaR, R TikariyaK, B. Payal
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引用次数: 0

摘要

目的:采用紫外分光光度法对复方片剂的标签要求进行校核。方法:分光光度法的开发和验证在药品的开发和生产中起着重要的作用。建立了测定片剂中对乙酰氨基酚和咖啡因含量的分光光度法,该方法简便、重复性好。根据ICH指南对特异性、线性、精密度、准确度、稳健性和坚固性等参数进行了研究。以蒸馏水为溶剂测定咖啡因的波长选择273nm,以蒸馏水为溶剂测定对乙酰氨基酚的波长选择243nm。在20 ~ 120µg/ml浓度范围内,药物符合比尔-兰伯特定律。回收率研究证实了该方法的准确性。该方法成功地应用于该制剂的常规分析,并按照ICH指南进行验证。结论:建立了一种不受辅料干扰的紫外分光光度法同时测定片剂中对乙酰氨基酚和咖啡因含量的方法。本方法采用简单的样品制备方法,取得了满意的萃取回收率,便于在共配制剂中应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
To Estimate the Label claim of tablet in their combination by simultaneous estimation using UV-Visible Spectrophotometric method
Objective: The main objective of the work was to check the label claim of tablet in combination by Simultaneous estimation by UV method. Method: Spectrophotometric method development and validation are plays important role in the development and manufacture of pharmaceuticals. This Spectrophotometric method was a simple and reproducible for the quantitative determination of Paracetamol and Caffeine in tablet formulation was developed and validated in the present work. The various parameters like specificity, linearity, precision, accuracy, robustness and ruggedness were studied according to ICH guidelines. The wavelength 273nm was selected for the estimation of Caffeine using distilled water as a solvent and the wavelength 243nm selected for the estimation of Paracetamol using distilled water as solvent the drug obeyed Beer’s-Lambert’s law over the concentration range 20-120µg/ml. Recovery study was performed to confirm the accuracy of the method. The method was successfully applied for routine analysis of this drug in formulation the method were validated as pr ICH guidelines. Conclusion: A simple UV spectrophotometric method was developed for the Simultaneous determination of Paracetamol and Caffeine in tablet formulation without any interference from the excipients. The present method succeeded in adopting a simple sample preparation that achieve satisfactory extraction recovery and facilitated its application in co formulated formulation.
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