title: Simultaneous determination of the impurity and radial tensile strength of reduced glutathione tablets by a high selective NIR-PLS method.
abstract: This paper establishes a high-throughput and high selective method to determine the impurity named oxidized glutathione (GSSG) and radial tensile strength (RTS) of reduced glutathione (GSH) tablets based on near infrared (NIR) spectroscopy and partial least squares (PLS). In order to build and evaluate the calibration models, the NIR diffuse reflectance spectra (DRS) and transmittance spectra (TS) for 330 GSH tablets were accurately measured by using the optimized parameter values. For analyzing GSSG or RTS of GSH tablets, the NIR-DRS or NIR-TS were selected, subdivided reasonably into calibration and prediction sets, and processed appropriately with chemometric techniques. After selecting spectral sub-ranges and neglecting spectrum outliers, the PLS calibration models were built and the factor numbers were optimized. Then, the PLS models were evaluated by the root mean square errors of calibration (RMSEC), cross-validation (RMSECV) and prediction (RMSEP), and by the correlation coefficients of calibration (R(c)) and prediction (R(p)). The results indicate that the proposed models have good performances. It is thus clear that the NIR-PLS can simultaneously, selectively, nondestructively and rapidly analyze the GSSG and RTS of GSH tablets, although the contents of GSSG impurity were quite low while those of GSH active pharmaceutical ingredient (API) quite high. This strategy can be an important complement to the common NIR methods used in the on-line analysis of API in pharmaceutical preparations. And this work expands the NIR applications in the high-throughput and extraordinarily selective analysis.
authors.affiliation: School of Pharmacy, Chongqing Medical University, Chongqing 400016, China.
authors.forename: Juan
authors.initials: J
authors.lastname: Li
authors.affiliation: Enterprise Technology Center, Chongqing Yaoyou Pharmaceutical Co., Ltd, Chongqing 401121, China.
authors.forename: Yue
authors.initials: Y
authors.lastname: Jiang
authors.affiliation: School of Pharmacy, Chongqing Medical University, Chongqing 400016, China. Electronic address: fanqi787@gmail.com.
authors.forename: Qi
authors.initials: Q
authors.lastname: Fan
authors.affiliation: School of Pharmacy, Chongqing Medical University, Chongqing 400016, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Chen
authors.affiliation: School of Pharmacy, Chongqing Medical University, Chongqing 400016, China.
authors.forename: Ruanqi
authors.initials: R
authors.lastname: Wu
mesh_terms: D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D005978:Glutathione / Q000737:chemistry*; D019803:Glutathione Disulfide / Q000737:chemistry; D016018:Least-Squares Analysis; D008958:Models, Molecular; D015203:Reproducibility of Results; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013607:Tablets; D013718:Tensile Strength
chemical_list: D013607:Tablets; D005978:Glutathione; D019803:Glutathione Disulfide
keywords: Chemometrics; Impurity; Near infrared spectroscopy; Reduced glutathione tablets; Tablet radial tensile strength