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Near infrared spectroscopic transmittance measurements for pharmaceutical powder mixtures.
J Pharm Biomed Anal. 2016 May 10; 123:120-7.JP

Abstract

This study describes the development of near infrared (NIR) calibration models using transmittance measurements in powder samples and compares the results obtained with those of tablet transmittance and diffuse reflectance of powders. Transmission near infrared spectroscopy is a method widely used for the analysis of tablets in the evaluation of drug concentration due to the larger sample volume analyzed, but not commonly used for the analysis of powder samples. Diffuse reflection near infrared spectroscopy is a method used in both powder and tablets for the evaluation of quality attributes. In this initial study NIR transmittance measurements were obtained using an off-line spectrometer equipped with a high intensity light source. Spectra were obtained with three different resolutions for the analysis of powder and tablet samples of 7.50-22.50% (w/w) acetaminophen. The Partial Least Squares (PLS) calibration models developed include pretreatments such as Standard Normal Variate (SNV) and first derivative in the region from 9500-7500 cm(-1). Transmittance in powder presented low Root Mean Square Error of Prediction (RMSEP) values that varied from 0.23-1.15% (w/w) APAP with resolution of 64 and 16 cm(-1). The lowest RMSEP values (0.23-0.39% (w/w) APAP) were obtained using a resolution of 64 cm(-1). The RMSEP values for powder transmittance measurements were 2.4-5.6 times lower than the diffuse reflectance measurements of the powder mixtures.

Authors+Show Affiliations

Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), Department of Chemistry, University of Puerto Rico Mayaguez Campus, PO Box 9000, Mayaguez, PR 00681, USA.Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), Department of Chemistry, University of Puerto Rico Mayaguez Campus, PO Box 9000, Mayaguez, PR 00681, USA.Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), Department of Chemistry, University of Puerto Rico Mayaguez Campus, PO Box 9000, Mayaguez, PR 00681, USA.Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), Department of Chemistry, University of Puerto Rico Mayaguez Campus, PO Box 9000, Mayaguez, PR 00681, USA.Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), Department of Chemistry, University of Puerto Rico Mayaguez Campus, PO Box 9000, Mayaguez, PR 00681, USA.Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), Department of Chemistry, University of Puerto Rico Mayaguez Campus, PO Box 9000, Mayaguez, PR 00681, USA. Electronic address: rodolfoj.romanach@upr.edu.

Pub Type(s)

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

Language

eng

PubMed ID

26895497

Citation

Sánchez-Paternina, Adriluz, et al. "Near Infrared Spectroscopic Transmittance Measurements for Pharmaceutical Powder Mixtures." Journal of Pharmaceutical and Biomedical Analysis, vol. 123, 2016, pp. 120-7.
Sánchez-Paternina A, Román-Ospino AD, Martínez M, et al. Near infrared spectroscopic transmittance measurements for pharmaceutical powder mixtures. J Pharm Biomed Anal. 2016;123:120-7.
Sánchez-Paternina, A., Román-Ospino, A. D., Martínez, M., Mercado, J., Alonso, C., & Romañach, R. J. (2016). Near infrared spectroscopic transmittance measurements for pharmaceutical powder mixtures. Journal of Pharmaceutical and Biomedical Analysis, 123, 120-7. https://doi.org/10.1016/j.jpba.2016.02.006
Sánchez-Paternina A, et al. Near Infrared Spectroscopic Transmittance Measurements for Pharmaceutical Powder Mixtures. J Pharm Biomed Anal. 2016 May 10;123:120-7. PubMed PMID: 26895497.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Near infrared spectroscopic transmittance measurements for pharmaceutical powder mixtures. AU - Sánchez-Paternina,Adriluz, AU - Román-Ospino,Andrés D, AU - Martínez,Mirna, AU - Mercado,Joseph, AU - Alonso,Camila, AU - Romañach,Rodolfo J, Y1 - 2016/02/08/ PY - 2015/10/23/received PY - 2016/02/02/revised PY - 2016/02/05/accepted PY - 2016/2/20/entrez PY - 2016/2/20/pubmed PY - 2016/12/15/medline KW - Diffuse reflection KW - Multivariate analysis KW - Partial least squares (PLS) KW - Pharmaceutical analysis KW - Process analytical technology KW - Transmission SP - 120 EP - 7 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 123 N2 - This study describes the development of near infrared (NIR) calibration models using transmittance measurements in powder samples and compares the results obtained with those of tablet transmittance and diffuse reflectance of powders. Transmission near infrared spectroscopy is a method widely used for the analysis of tablets in the evaluation of drug concentration due to the larger sample volume analyzed, but not commonly used for the analysis of powder samples. Diffuse reflection near infrared spectroscopy is a method used in both powder and tablets for the evaluation of quality attributes. In this initial study NIR transmittance measurements were obtained using an off-line spectrometer equipped with a high intensity light source. Spectra were obtained with three different resolutions for the analysis of powder and tablet samples of 7.50-22.50% (w/w) acetaminophen. The Partial Least Squares (PLS) calibration models developed include pretreatments such as Standard Normal Variate (SNV) and first derivative in the region from 9500-7500 cm(-1). Transmittance in powder presented low Root Mean Square Error of Prediction (RMSEP) values that varied from 0.23-1.15% (w/w) APAP with resolution of 64 and 16 cm(-1). The lowest RMSEP values (0.23-0.39% (w/w) APAP) were obtained using a resolution of 64 cm(-1). The RMSEP values for powder transmittance measurements were 2.4-5.6 times lower than the diffuse reflectance measurements of the powder mixtures. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/26895497/Near_infrared_spectroscopic_transmittance_measurements_for_pharmaceutical_powder_mixtures_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(16)30068-1 DB - PRIME DP - Unbound Medicine ER -