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Simultaneous determination of the impurity and radial tensile strength of reduced glutathione tablets by a high selective NIR-PLS method.
Spectrochim Acta A Mol Biomol Spectrosc. 2014 May 05; 125:278-84.SA

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+Show Affiliations

School of Pharmacy, Chongqing Medical University, Chongqing 400016, China.Enterprise Technology Center, Chongqing Yaoyou Pharmaceutical Co., Ltd, Chongqing 401121, China.School of Pharmacy, Chongqing Medical University, Chongqing 400016, China. Electronic address: fanqi787@gmail.com.School of Pharmacy, Chongqing Medical University, Chongqing 400016, China.School of Pharmacy, Chongqing Medical University, Chongqing 400016, China.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24556136

Citation

Li, Juan, et al. "Simultaneous Determination of the Impurity and Radial Tensile Strength of Reduced Glutathione Tablets By a High Selective NIR-PLS Method." Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy, vol. 125, 2014, pp. 278-84.
Li J, Jiang Y, Fan Q, et al. Simultaneous determination of the impurity and radial tensile strength of reduced glutathione tablets by a high selective NIR-PLS method. Spectrochim Acta A Mol Biomol Spectrosc. 2014;125:278-84.
Li, J., Jiang, Y., Fan, Q., Chen, Y., & Wu, R. (2014). Simultaneous determination of the impurity and radial tensile strength of reduced glutathione tablets by a high selective NIR-PLS method. Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy, 125, 278-84. https://doi.org/10.1016/j.saa.2014.01.097
Li J, et al. Simultaneous Determination of the Impurity and Radial Tensile Strength of Reduced Glutathione Tablets By a High Selective NIR-PLS Method. Spectrochim Acta A Mol Biomol Spectrosc. 2014 May 5;125:278-84. PubMed PMID: 24556136.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Simultaneous determination of the impurity and radial tensile strength of reduced glutathione tablets by a high selective NIR-PLS method. AU - Li,Juan, AU - Jiang,Yue, AU - Fan,Qi, AU - Chen,Yang, AU - Wu,Ruanqi, Y1 - 2014/02/04/ PY - 2013/11/17/received PY - 2014/01/17/revised PY - 2014/01/26/accepted PY - 2014/2/22/entrez PY - 2014/2/22/pubmed PY - 2014/12/15/medline KW - Chemometrics KW - Impurity KW - Near infrared spectroscopy KW - Reduced glutathione tablets KW - Tablet radial tensile strength SP - 278 EP - 84 JF - Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy JO - Spectrochim Acta A Mol Biomol Spectrosc VL - 125 N2 - 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. SN - 1873-3557 UR - https://www.unboundmedicine.com/medline/citation/24556136/Simultaneous_determination_of_the_impurity_and_radial_tensile_strength_of_reduced_glutathione_tablets_by_a_high_selective_NIR_PLS_method_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-1425(14)00118-8 DB - PRIME DP - Unbound Medicine ER -