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Magnetochemistry
Volume 11
Issue 9
10.3390/magnetochemistry11090079
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Quantitative Analysis of the Components of Rotigotine Prolonged-Release Microspheres for Injection Using Solvent-Suppressed 1H NMR

by
Xiaoli Zhou
1,
Zengxin Li
2,
Xue Ni
2,
Wanhui Liu
2,3,* and
Lihui Yin
1,*
1
Key Laboratory for Quality Research and Evaluation of Chemical Drugs, National Institutes for Food and Drug Control, Beijing 102629, China
2
Key Laboratory of Molecular Pharmacology and Drug Evaluation, Ministry of Education, School of Pharmacy, Yantai University, Yantai 264003, China
3
State Key Laboratory of Advanced Drug Delivery and Release Systems, Luye Pharma Group, Yantai 264003, China
*
Authors to whom correspondence should be addressed.
Magnetochemistry 2025, 11(9), 79; https://doi.org/10.3390/magnetochemistry11090079
Submission received: 8 July 2025 / Revised: 31 August 2025 / Accepted: 3 September 2025 / Published: 4 September 2025
Versions Notes

Abstract

We developed a solvent-suppressed 1H nuclear magnetic resonance (NMR) method for the quantitative analysis of the components of rotigotine prolonged-release microspheres prepared for injection. Dimethyl terephthalate was used as an internal standard and dimethylsulfoxide -d6 as the solvent. The analysis was performed using a Bruker Avance III HD 600 MHz NMR spectrometer, employing the noesygppr1d pulse sequence at a controlled temperature of 25 °C. Nuclear magnetic resonance spectra were acquired with a relaxation delay time (D1) of 40 s to simultaneously determine the content of rotigotine and the excipients mannitol and stearic acid in the rotigotine prolonged-release microspheres. Using the proposed approach, we successfully quantified the active pharmaceutical ingredient rotigotine and excipients in the prolonged-release microspheres. This method demonstrated excellent linearity, high precision, and strong repeatability. The solvent-suppressed 1H NMR method developed in this study allows for the simultaneous quantification of rotigotine and the key excipients mannitol and stearic acid in the prolonged-release microspheres. This approach is accurate, simple, efficient, and environmentally friendly.
Keywords: quantitative NMR; rotigotine prolonged-release microspheres for injection; content determination; solvent suppression; 1H NMR quantitative NMR; rotigotine prolonged-release microspheres for injection; content determination; solvent suppression; 1H NMR

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MDPI and ACS Style

Zhou, X.; Li, Z.; Ni, X.; Liu, W.; Yin, L. Quantitative Analysis of the Components of Rotigotine Prolonged-Release Microspheres for Injection Using Solvent-Suppressed 1H NMR. Magnetochemistry 2025, 11, 79. https://doi.org/10.3390/magnetochemistry11090079

AMA Style

Zhou X, Li Z, Ni X, Liu W, Yin L. Quantitative Analysis of the Components of Rotigotine Prolonged-Release Microspheres for Injection Using Solvent-Suppressed 1H NMR. Magnetochemistry. 2025; 11(9):79. https://doi.org/10.3390/magnetochemistry11090079

Chicago/Turabian Style

Zhou, Xiaoli, Zengxin Li, Xue Ni, Wanhui Liu, and Lihui Yin. 2025. "Quantitative Analysis of the Components of Rotigotine Prolonged-Release Microspheres for Injection Using Solvent-Suppressed 1H NMR" Magnetochemistry 11, no. 9: 79. https://doi.org/10.3390/magnetochemistry11090079

APA Style

Zhou, X., Li, Z., Ni, X., Liu, W., & Yin, L. (2025). Quantitative Analysis of the Components of Rotigotine Prolonged-Release Microspheres for Injection Using Solvent-Suppressed 1H NMR. Magnetochemistry, 11(9), 79. https://doi.org/10.3390/magnetochemistry11090079

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