拉曼光谱法用于牛磺酸片鉴别及含量测定

Identification and assay of Taurine tablets by Raman spectroscopy

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 method for the identification and assay of Taurine tablets by Raman spectroscopy, and compare it with the 2015 ChP method. Methods： Taking Taurine tablets as the research object. The tablets were extracted by water and then filtered. The filtrate was identified and determined by a Raman spectrometer. Determination conditions were as follows： excitation wavelength： 780 nm; laser power： 120 mW; aperture： 50 Ix m; focus height： 6.0 mm; resolution： 1.0 cm-1; exposure time： 60 s; exposure times： 3; scanning range： 0-3 500 cm-l. Results： The calibration curve was linear over the range of 5-80 mg· mL-1 and the linear regression equation was Y=123.48X＋142.5 （r=0.999 2, n=6 ）. The average recoveries at low, medium and high concentrations were 97.9%, 99.5% and 100.3%, with RSD of 1.2%, 1.7% and 0.9%, respectively.Contents of taurine in 6 batches of samples were 99.6%, 97.5%, 98.7%, 98.4%, 96.6% and 101.5% of the labeled value, which were consistent with the results determined by the potentiometric titration method specified in 2015 ChP. Conclusion： The method was convenient and repeatable. Method validation results showed that Raman spectroscopy could be applied in identification and accurate assay of Taurine tablets, thus offered an analytical method for the quality control of Taurine tablets.