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目的:建立拉曼光谱法鉴别和测定牛磺酸片,并与药典方法比较。方法:以牛磺酸片作为研究对象,用水溶液提取其主成分并过滤,用拉曼光谱仪对样品溶液进行鉴别和含量测定。测定条件:激发波长780 nm,激光强度120 mW,光圈50μm,聚焦高度6.0 mm,分辨率1.0 cm~(-1),曝光时间60 s,曝光次数3次,扫描范围0~3 500 cm~(-1)。结果:牛磺酸质量浓度在5~80 mg·mL~(-1)范围内与拉曼峰面积呈良好线性关系,线性回归方程为Y=123.48X+142.51,相关系数为0.999 2(n=6);低、中、高3个浓度的平均回收率分别为97.9%、99.5%、100.3%,RSD分别为1.2%、1.7%、0.9%,6个批次样品牛磺酸含量测定结果分别为标示量的99.6%、97.5%、98.7%、98.4%、96.6%、101.5%,与2015年版中国药典标准收载的电位滴定方法测定结果基本一致。结论:本方法操作简单,重复性好,经方法验证,拉曼光谱法可以鉴别牛磺酸片,并能准确测定片剂中的牛磺酸含量,可作为牛磺酸片质量控制的分析方法。
OBJECTIVE: To establish a Raman spectroscopic method for the identification and determination of taurine tablets and to compare with the pharmacopoeia method. Methods: Taurine tablets were taken as the research object. The main components were extracted with aqueous solution and filtered. The sample solutions were identified and determined by Raman spectroscopy. The measurement conditions were as follows: excitation wavelength 780 nm, laser intensity 120 mW, aperture 50 μm, focusing height 6.0 mm, resolution 1.0 cm -1, exposure time 60 s, exposure times 3 times, scanning range 0-3 500 cm ~ -1). Results: The taurine concentration showed a good linear relationship with Raman peak area in the range of 5-80 mg · mL -1. The linear regression equation was Y = 123.48X + 142.51 with a correlation coefficient of 0.999 2 (n = 6). The average recoveries of low, medium and high concentrations were 97.9%, 99.5% and 100.3%, respectively, with RSDs of 1.2%, 1.7% and 0.9%, respectively It is 99.6%, 97.5%, 98.7%, 98.4%, 96.6% and 101.5% of the labeled amount, which is basically consistent with the results of the potentiometric titration method contained in the 2015 edition of the Chinese Pharmacopoeia standard. Conclusion: The method is easy to operate and has good reproducibility. The method can be used to identify taurine tablets by the method of Raman spectroscopy and to accurately determine the content of taurine in the tablets. The method can be used as an analytical method for the quality control of taurine tablets .