Development and Validation of Near-infrared Method in the Accuracy Determination of Baicalin in Shuanghuanglian Oral Liquid
双黄连口服液中黄芩苷含量近红外测定方法的建立与验证

This study was aimed to develop and validate a near-infrared(NIR) method to accurately determine baicalin in the Shuanghuanglian oral liquid.Transmission mode was used in the collection of NIR spectral samples.A robust PLS model was established based on the correlation between the NIR spectrum and HPLC reference.And quantitative property of the established model was evaluated through indexes of R,RMSEC,and RMSEP.The accuracy profile was introduced as a new method to validate the accuracy and trueness of the model.The results showed that conventional criteria such as the R,RMSEC,and RMSEP are 0.9902,0.4223 and 0.4162,respectively.The limit of quality(LOQ) of the model is from 5.324 mg/mL to 11.14 mg/mL when the β-expectations tolerance limits,accept limit and risk profile was at 95%,12% and 5%,respectively.The results were with high truness,intermediate precision and recovery.It was concluded that the NIR quantitative model of baicalin in Shuanghuanglian oral liquid is reliable.In addition,accuracy profile as a new validation method which can be used to evaluate NIR model in traditional Chinese medicine.