Quality Control of Troxerutin for Injection by Near Infrared Spectroscopy
The quantitative analysis and prediction model of troxerutin for injection is established by near infrared spectroscopy and related validation is performed.Near infrared integrating sphere diffuse reflectance spectroscopy is used to collect 73 batches of samples and obtain near infrared spectra.The active ingredient content of samples is determined by HPLC and the pH value of the samples is measured.The quantitative analysis method model is established by partial least squares(PLS)using TQ Analyst spectral analysis software.According to the model,the linear correlation coefficient R(Corr.Coeff)of the content prediction model is 0.99239,the corrected standard deviation(RMSEC)and prediction standard deviation(RMSEP)are 0.1790 and 0.5460,respectively,the R of the pH prediction model is 0.81575,the RMSEC and RMSEP are 0.0749 and 0.0704,respectively.The validation results show that the mean error rates of the external validation results of the assay and pH prediction models are 0.46％and 1.57％,respectively,and there is no significant difference in the t test(P＞0.05).NIRS analysis technology can quickly and stably predict product content and pH value,providing a new method basis for product quality control.
Near infrared spectrum(NIRS)Quantitative modelTroxerutin for injectionQuality control
万方数据
维普
