FTIR光谱法测定依非韦伦原料药和片剂剂型

N. P. Reddy, Y. Padmavathi, P. Mounika, Akari Anjali
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引用次数: 13

摘要

建立了一种快速、直接测定制剂中依非韦伦的傅里叶变换红外分光光度法。该方法包括用超声波从氯仿片中提取依非韦伦,并使用减径池直接测量液相吸光度。一般情况下,频谱是在传输模式下测量的。在4000 cm -1 ~ 450cm -1范围内采集光谱,在1750cm -1(羰基)处获得的光谱在液相中显示出强烈、清晰的峰,便于定量。该方法按照ICH指南进行了验证。该方法在200 ~ 1000µg/mL线性范围内满足大部分验证要求。测定系数为0.993,检出限为49.12μg/mL,定量限为148.84μg/mL。采用t检验对所建立的FTIR方法的结果与现有UV方法的结果进行统计学比较,P=0.05时,两种方法间差异无统计学意义。所提出的FTIR方法减少了溶剂的消耗,也消除了试剂的使用。因此,所开发的方法为散装和药物剂型的依非韦伦的定量估计以及与相同剂型的其他原料药联合时的依非韦伦的定量估计提供了一个很好的替代方法。国际药学杂志,2015,4(6):390-395
本文章由计算机程序翻译,如有差异,请以英文原文为准。
FTIR spectroscopy for estimation of efavirenz in raw material and tablet dosage form
A Fourier transform infrared (FTIR) spectrophotometric method was developed for rapid and direct measurement of efavirenz in pharmaceutical formulations. The method involves extraction of efavirenz from tablets with chloroform by sonication and the direct measurement of the absorbance in liquid phase using a reduced path length cell. In general, the spectrum was measured in transmission mode. The equipment was configured to collect a spectrum at 8 cm -1 resolution and 45 scans per sec .The spectra were collected between 4000 cm -1 and 450cm -1 , the band obtained at 1750cm -1 (carbonyl group) showed intense, clear peak in the liquid phase for quantitation. The method was validated as per ICH guidelines. The method fulfilled most validation requirements in the linearity range 200-1000µg/mL. The coefficient of determination, limit of detection and quantification was found to be 0.993, 49.12μg/mL and 148.84μg/mL respectively. Results of developed FTIR method were compared with the results obtained with the existing UV method statistically by using t-test, which indicated that there is no significant difference between the methods at P=0.05. The proposed FTIR method reduces the solvent consumption and also eliminates the use of reagents. Thus the developed method offers a good alternative for the quantitative estimation of efavirenz in bulk and pharmaceutical dosage forms and also to quantify efavirenz when combined with other API in the same dosage form. International Current Pharmaceutical Journal, May 2015, 4(6): 390-395
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