Qualitative Analysis Of Two Kinds Of Excipients And Quality Analysis Of HPMC By NIRS

Excipients,as an indispensible part of the pharmaceutical preparation,are not seen as inert component other than active pharmaceutical ingredient(API)any more in the pharmaceutical formulations.They are used as fillers,binder,disintegrant and carrier material to improve the compatibility of powder,to modulate drug release,to enhance stability of API,and to facilitate patient compliance.The consistency of excipients quality significantly influence the final quality of the drug.They require strict control to improve the quality and reduce the lot to lot variability.Near infrared spectroscopy(AIRS)as a process analytical technology has the character of convenience,fastness,and non-destructive compared with other traditional methods.It can be used in the manufacturing process to identify starch additives and cellulose additives.Then.HPMC as the feature excipients,was qualitative and quantitative analysis by NIRS.The details are listed as below:(1)Research on identification of starch additives and cellulose additives by using NIRSIn this study.Two types of near infrared spectrometers namely Thermo Antaris Ⅱ,Micro NIR spectrometer were employed to indentify starch additives and cellulose additives.The qualitative method mainly were Principal Component Analysis(PCA)and Partial Least Square discriminate analysis(PLS-DA).Firstly.PCA was selected for identification of the two classes.Secondly.PLS-DA was employed to indentify the excipients which cannot be discriminated by PCA.The study demonstrated that both spectrometers were used to indentify starch additives and cellulose additives.Although relatively few spectra variables were collected by Micro NIR,they covered the important information about samples.The results obtained by Micro NIR can meet the needs of pharmaceutical manufacturing.(2)Research on identification of different manufactures’ HPMC and different viscosity grades of HPMC by using NIRSIn this study,The fiber part of NIRS was chosen to indentify different manufactures’HPMC and different viscosity grades of HPMC.In the research on identification of different manufactures’ HPMC,linear pattern recognition method PLS-DA and non-linear pattern recognition method SVM-DA the two methods were used to establish the qualitative model.The study showed that sensitivity and specificity of SVM-DA method was superior to PLS-DA method.The sensitivity and specificity of calibration were both above 0.90.the validation both 1.00.In the research on identification different viscosity grades of HPMC.unsupervised pattern recognition method KNN and supervised pattern recognition method PLS-DA were compared to construct the qualitative models.The study showed that PLS-DA was better than KNN.The study showed that identification of different manufactures’ HPMC and viscosity can be achieved by fiber optics probe.(3)Research on hydroxypropoxy group and methoxy group determination on the backbone of HPMC molecular by using NIRSThis study mainly focused on combination of near infrared spectroscopy and chemometrics to determine the content of hydroxypropoxy group and methoxy group in HPMC.Before the establishment of PLS model,gas chromatography method was adopted to determine the reference data.Then.PLS model was established.To construct the best model,several influence factors,including sample set selection methods,spectral pre-processing methods were investigated in detail.Finally,best models for hydroxypropoxy group and methoxy group content determination were obtained,and the values of hydroxypropoxy group Rc,Rp,RMSEC,and RMSEP were 0.997,0.983,0.0799,0.132,respectively,the values of methoxy group Rc,Rp,RMSEC and RMSEP were 0.980,0.973,0.671,0.771,respectively.The results showed that PLS models had excellent predictive ability and robustness.The innovation points are listed as below:(1)This paper investigated variable selection methods and employed iPLS-CARS to optimize model,making the model robust and more predictive.(2)This research established qualitative models of different manufactures’ HPMC and HPMC viscosity by using NIRS for the first time.(3)This research brought NIRS to determine the content of hydroxypropoxy and methoxy group of HPMC firstly.This provide a foundation for rapid quality analysis of HPMC.