OBJECTIVE To establish a method for the rapid determination of dimethylsilicone oil content in aluminum magnesium dimethylsilicone oil chewable tablets, provide a rapid and effective means for the quality control of aluminum magnesium dimethylsilicone oil chewable tablets, and provide a reference for the rapid determination of dimethylsilicone oil in other solid preparations.
METHODS Attenuated total reflection Fourier transform infrared spectroscopy(ATR-FTIR) was used to determine the characteristic absorption peak of dimethylsilicone oil at 1 260 cm−1, and the content of dimethylsilicone oil in aluminum magnesium dimethylsilicone oil chewable tablets with unknown content was determined with the standard curve of dimethylsilicone oil content-corrected absorbance, and the difference was tested by F test and t test.
RESULTS The content of dimethylsilicone oil in aluminum magnesium dimethylsilicone oil chewable tablets was linear in the range of 2.0%−100.0%, and the correlation coefficient r was 0.999 6(n=7). The stability of test product and control product was good within 2 h. There was no significant difference between the established ATR-FTIR method and the previous method.
CONCLUSION The established two-wave number ATR-FTIR method has exhibits excellent specificity, good reproducibility, high instrumental precision, and high accuracy. Additionally, it is safe, environmentally friendly, and rapid, and can be used as a method for the determination of dimethylsilicone oil content in aluminum magnesium dimethylsilicone oil chewable tablets, and also as a potential rapid determination method for dimethylsilicone oil content in other solid preparations.