The application of quantitative NMR for the facile, rapid and reliable determination of clindamycin phosphate in a conventional tablet formulation

Copyright © 2014 John Wiley & Sons, Ltd.

Bibliographische Detailangaben
Veröffentlicht in:Magnetic resonance in chemistry : MRC. - 1985. - 52(2014), 4 vom: 14. Apr., Seite 178-82
1. Verfasser: Liang, Xianrui (VerfasserIn)
Weitere Verfasser: Du, Liping, Su, Feng, Parekh, Harendra S, Su, Weike
Format: Online-Aufsatz
Sprache:English
Veröffentlicht: 2014
Zugriff auf das übergeordnete Werk:Magnetic resonance in chemistry : MRC
Schlagworte:Journal Article 1H NMR NMR clindamycin phosphate drug validation quality control quantitative NMR Tablets Clindamycin 3U02EL437C EH6D7113I8
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520 |a Spectroscopic tools such as NMR can be applied to the quantitative analysis of active pharmaceutical ingredients with relative ease and accuracy. Here, we demonstrate the quantification of clindamycin phosphate (CLP) in a conventional tablet formulation, performed using potassium hydrogen phthalate (KHP) as the internal standard and deuterium oxide (D2O) as the NMR solvent. The methyl protons signal of CLP at 0.72 ppm (triplet) relative to the signal of KHP at 7.37-7.40 ppm (multiplet) was used for quantification purposes using (1)H NMR. This method was shown to be specific and linear (r = 0.9997) within the CLP concentration range from 7.2 to 23.1 mg per 0.5 ml of D2O. The maximum relative standard deviation (RSD) of accuracy and precision was calculated at 0.39% and 0.64%, respectively. The limits of detection (LOD) and quantification were 0.04 and 0.11 mg/ml, respectively. The method was highly stable with a calculated RSD of 0.03%. The robustness of the method was demonstrated by changing four different parameters, and the difference among each parameter was ≤ 0.78%. The findings of this work were in good agreement with previously reported conventional HPLC-based approaches, highlighting its applicability in the determination of other active pharmaceutical ingredients in conventional formulations for quality control purposes 
650 4 |a Journal Article 
650 4 |a 1H NMR 
650 4 |a NMR 
650 4 |a clindamycin phosphate 
650 4 |a drug validation 
650 4 |a quality control 
650 4 |a quantitative NMR 
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650 7 |a Clindamycin  |2 NLM 
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650 7 |a clindamycin phosphate  |2 NLM 
650 7 |a EH6D7113I8  |2 NLM 
700 1 |a Du, Liping  |e verfasserin  |4 aut 
700 1 |a Su, Feng  |e verfasserin  |4 aut 
700 1 |a Parekh, Harendra S  |e verfasserin  |4 aut 
700 1 |a Su, Weike  |e verfasserin  |4 aut 
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773 1 8 |g volume:52  |g year:2014  |g number:4  |g day:14  |g month:04  |g pages:178-82 
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