双波数ATR-FTIR法快速测定铝镁二甲硅油咀嚼片中二甲硅油含量

Rapid determination of dimethicone content in aluminum magnesium dimethicone chewable tablets by ATR-FTIR using double wavenumber calculation

关键词:  ATR  FTIR  铝镁二甲硅油咀嚼片  二甲硅油  快速测定  最小二乘法  F检验  T检验

Key words:  ATR  FTIR  Aluminum magnesium dimethicone chewable tablets  Dimethicone  Rapid determination  PLS  F test  T test

摘要:

目的：建立一种能快速测定铝镁二甲硅油咀嚼片中二甲硅油含量的方法,为铝镁二甲硅油咀嚼片质量控制提供快速有效的手段,同时为其他固体制剂中二甲硅油的测定提供一种潜在的快速手段。方法：运用ATR-FTIR,在1260cm_-1^{波数处测定二甲硅油的特征吸收峰,以二甲硅油含量-峰高的标准曲线对}未知含量的铝镁二甲硅油咀嚼片中二甲硅油含量进行测定,并以F检验和t检验法验证ATR-FTIR法与以往方法的差异性。结果：铝镁二甲硅油咀嚼片中二甲硅油浓度在0.11～53.70μg.mL_-1^范围内线性良好,相关系数r为0.9990(n=7),供试品与对照品在2h内稳定性良好；建立的ATR-FTIR法与以往方法检测结果无显著性差异。结论: 建立的双波数ATR-FTIR法专属性佳、重现性好、精密度优、准确度高,且安全、环保、快速,可作为铝镁二甲硅油咀嚼片中二甲硅油的含量测定方法,也可作为其他固体制剂中二甲硅油含量的潜在快速测定方法。

Abstract:

Objective: To establish a rapid method for the determination of dimethyl silicone oil in aluminum-magnesium dimethyl silicone oil chewable tablets, so as to provide a rapid and effective method for the quality control of aluminum-magnesium dimethyl silicone oil chewable tablets, and provide a potential rapid method for the determination of dimethyl silicone oil in other solid preparations. Methods: ATR-FTIR was used to determine the characteristic absorption peak of dimethyl silicone oil at 1260cm_^-1 wave number, and the content of dimethyl silicone oil in aluminum magnesium dimethyl silicone oil chewable tablets with unknown content was determined by the standard curve of dimethyl silicone oil content - peak height. F-test and t-test were used to verify the difference between ATR-FTIR method and previous methods. Results: The concentration of dimethyl silicone oil in aluminum-magnesium dimethyl silicone oil chewable tablets was in the range of 0.11 ~ 53.70μg. ml_^-1, and the correlation coefficient R was 0.9990(n=7). The test product and control product had good stability within 2 hours. There was no significant difference between the ATR-FTIR method and the previous methods. Conclusion: The established Double-wavelengths ATR-FTIR method has good specificity, reproducibility, precision, high accuracy, safety, environmental protection, and rapid. It can be used as a method for the determination of dimethyl silicone oil in aluminum magnesium dimethyl silicone oil chewable tablets, and can also be used as a potential rapid method for the determination of dimethyl silicone oil in other solid preparations.