Rapid Determination of Acarbose in Tablets by 1H NMR Spectroscopy

Author(s): Cong Wang, Xiuli Zhang, Mingming Yu*

Journal Name: Current Pharmaceutical Analysis

Volume 16 , Issue 5 , 2020

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Graphical Abstract:


Introduction: Acarbose, an anti-diabetic drug, is commonly used to treat diabetes mellitus type 2. Determinationof acarbose is crucial for routine quality control of acarbose tablets.

Materials and Methods: In this report, a rapid, stable and precise method was developed and validated for the quantification of acarbose in tablets by 1H NMR. Two characteristic signals at 5.80 and 2.31 ppm were used to determine acarbose. The assay was linear over a concentration range of 0.25-10.0 mg/mL. The precision was 0.26% and 1.02% for signals at 5.80 and 2.31 ppm, respectively. The average recoveries of acarbose were 99.7% and 99.2%, with RSD values 0.51% and 0.61% at two signals, respectively.

Results and Discussion: The content of tested tablets was 100.4% and 100.8% of the label claim with RSD values 0.96% and 1.47% at two signals, which met the requirement of Chinese Pharmacopoeia criteria for content uniformity of tablets. The assay has been successfully applied to determine the content of acarbose in tablets for quality evaluation.

Conclusion: This method has been successfully applied to determine the content of acarbose in tablets for quality evaluation.

Keywords: Acarbose tablet, 1H NMR, quality evaluation, assay validation, tablets, type 2 diabetes.

Scheen, A.J. Clinical efficacy of acarbose in diabetes mellitus: a critical review of controlled trials. Diabetes Metab., 1998, 24(4), 311-320.
[PMID: 9805641]
Clissold, S.P.; Edwards, C. Acarbose. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs, 1988, 35(3), 214-243.
[http://dx.doi.org/10.2165/00003495-198835030-00003] [PMID: 3286212]
Chiasson, J-L.; Josse, R.G.; Gomis, R.; Hanefeld, M.; Karasik, A.; Laakso, M. STOP-NIDDM Trail Research Group. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet, 2002, 359(9323), 2072-2077.
[http://dx.doi.org/10.1016/S0140-6736(02)08905-5] [PMID: 12086760]
Siddiqui, M.R.; AlOthman, Z.A.; Rahman, N. Analytical techniques in pharmaceutical analysis: A review. Arab. J. Chem., 2017, 10, S1409-S1421.
Rahman, N.; Azmi, S.N.H.; Wu, H.F. The importance of impurity analysis in pharmaceutical products: An integrated approach. Accredit. Qual. Assur., 2006, 11, 69-74.
Alothman, Z.; Rahman, N.; Siddiqui, M.R. Review on pharmaceutical impurities, stability studies and degradation products: an analytical approach. Rev. Adv. Sci. Eng., 2013, 2, 155-166.
Daali, Y.; Cherkaoui, S.; Cahours, X.; Varesio, E.; Veuthey, J-L. High performance liquid chromatography of acarbose and its metabolite on porous graphitic carbon column. J. Sep. Sci., 2002, 25, 280-284.
Wang, Y-J.; Zheng, Y-G.; Xue, Y-P.; Wang, Y-S.; Shen, Y-C. Analysis and determination of anti-diabetes drug acarbose and its structural analogs. Curr. Pharm. Anal., 2011, 7, 12-20.
Lachmann, B.; Noe, C.R. Determination of acarbose by capillary zone electrophoresis. Pharmazie, 2013, 68(7), 531-533.
[http://dx.doi.org/10.1691/ph.2013.6524] [PMID: 23923633]
Raut, B.B.; Kolte, B.L.; Deo, A.A.; Bagool, M.A.; Shinde, D.B. Quantification of acarbose in human plasma by liquid chromatography—electrospray tandem mass spectrometry. J. Liq. Chromatogr. Relat. Technol., 2004, 27, 1759-1768.
Saoud, A.; Akowuah, G.A.; Fatokun, O.; Mariam, A.; Khalivulla, S.I. Determination of acarbose in tablets by attenuated total reflectance Fourier transform infrared spectroscopy. Arch. Ind. Biotechnol., 2017, 1
Holzgrabe, U. Quantitative NMR spectroscopy in pharmaceutical R&D. Prog. Nucl. Magn. Reson. Spectrosc., 2015, 4, 45-56.
Schnell, I.; Spiess, H.W. High-resolution 1H NMR spectroscopy in the solid state: very fast sample rotation and multiple-quantum coherences. J. Magn. Reson., 2001, 151(2), 153-227.
[http://dx.doi.org/10.1006/jmre.2001.2336] [PMID: 11531343]
Zoppi, A.; Linares, M.; Longhi, M. Quantitative analysis of enalapril by 1H NMR spectroscopy in tablets. J. Pharm. Biomed. Anal., 2005, 37(3), 627-630.
[http://dx.doi.org/10.1016/j.jpba.2004.11.027] [PMID: 15740927]
Siciliano, C.; Belsito, E.; De Marco, R.; Di Gioia, M.L.; Leggio, A.; Liguori, A. Quantitative determination of fatty acid chain composition in pork meat products by high resolution 1H NMR spectroscopy. Food Chem., 2013, 136(2), 546-554.
[http://dx.doi.org/10.1016/j.foodchem.2012.08.058] [PMID: 23122096]
Xie, B.; Liu, A.; Fang, X.; Chen, Y.; Zhong, H. Rapid determination of alendronate to quality evaluation of tablets by high resolution 1H NMR spectroscopy. J. Pharm. Biomed. Anal., 2014, 93, 73-76.
[http://dx.doi.org/10.1016/j.jpba.2013.07.006] [PMID: 24215933]
Yang, Q.; Qiu, H.; Guo, W.; Wang, D.; Zhou, X.; Xue, D.; Zhang, J.; Wu, S.; Wang, Y. Quantitative 1H-NMR method for the determination of tadalafil in bulk drugs and its tablets. Molecules, 2015, 20(7), 12114-12124.
[http://dx.doi.org/10.3390/molecules200712114] [PMID: 26147583]
Maniara, G.; Rajamoorthi, K.; Rajan, S.; Stockton, G.W. Method performance and validation for quantitative analysis by (1)h and (31)p NMR spectroscopy. Applications to analytical standards and agricultural chemicals. Anal. Chem., 1998, 70(23), 4921-4928.
[http://dx.doi.org/10.1021/ac980573i] [PMID: 21644675]
Holzgrabe, U.; Deubner, R.; Schollmayer, C.; Waibel, B. Quantitative NMR spectroscopy--applications in drug analysis. J. Pharm. Biomed. Anal., 2005, 38(5), 806-812.
[http://dx.doi.org/10.1016/j.jpba.2005.01.050] [PMID: 15893899]
Zhang, X.L.; Wang, C.; Chen, Z.; Zhang, P.Y.; Liu, H.B. Development and validation of quantitative 1H NMR spectroscopy for the determination of total phytosterols in the marine seaweed sargassum. J. Agric. Food Chem., 2016, 64(31), 6228-6232.
[http://dx.doi.org/10.1021/acs.jafc.6b02904] [PMID: 27447194]
China Food and Drug Administration. CFDA guidelines for chemicals methods validation, 2005.
Bharti, S.K.; Roy, R. Quantitative1H NMR spectroscopy. TrAC -. Trends Analyt. Chem., 2012, 35, 5-26.

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Article Details

Year: 2020
Published on: 15 June, 2020
Page: [585 - 590]
Pages: 6
DOI: 10.2174/1573412915666181224125141
Price: $65

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