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Copyright (c) 2014 Masoom Raza Siddiqui1, Saikh Mohammad Wabaidur1, Zeid A. Alothman1, Moonis Ali Khan1, Mohammad Shamsul Ola2
This work is licensed under a Creative Commons Attribution 4.0 International License.
Quantitative Assessment of Cefuroxime: A Second Generation Cephalosporin in Pharmaceutical Formulations and Spiked Plasma Using Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry
Corresponding Author(s) : Masoom Raza Siddiqui1
Asian Journal of Chemistry,
Vol. 26 No. 24 (2014)
Abstract
A simple and rapid method has been developed for the determination of cefuroxime in pharmaceutical formulations and spiked plasma. The method involves the application of ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) for the quantitative assessment of cefuroxime. The chromatographic separation of the cefuroxime was carried out using BEH C18 column (100 mm × 2.1 mm, 1.7 μm particle size) using a binary mobile phase mixture of 1-octane sulfonic acid sodium salt (5.78 × 10-4 M) and acetonitrile (50:50, v/v) at a flow rate of 0.5 mL min-1. The UPLC-MS/MS have shorter analysis time of 1 min was found to be linear over the concentration range of 0.5-5 μg mL-1. Limit of detection and limit of quantitation of the UPLC-MS/MS method was obtained to be 0.10 and 0.301 μg mL-1. The method was validated as per the ICH guidelines. The recovery studies suggest an excellent recovery of the procedure which was found in the range of 99.94-100.47 % for the pharmaceutical formulation and 95.63 to 96.89 %. for the spiked plasma. The RSD range of the developed analytical procedure ranged from 0.90 %-1.68 % in intra-day studies and 1.42 %-1.97 %, respectively.
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- C.R. Gelman, B.H. Rumakc and T.A. Hutchinson; Product Information, Ceftin®, Cefuroxime Axetil. Glaxo Inc., Research Triangle Park, NC, USA, In: L DRUGEX® System; Micromedex Inc.: Englewood, CO, USA (1999).
- C. Dollery, Therapeutic Drugs, Churchill Livingstone, London, U.K., edn 2 (1999).
- Y.Y. Zhang, P.J. Wu and Q. Zhang, Zhonghua NeiKe ZaZhi, 28, 340 (1989).
- M.S. Al-Said, K.I. Al-Khamis, E.M. Niazy, Y.M. El-Sayed, K.A. Al-Rashood, S. Al-Bella, M.A. Al-Yamani, A. Al-Najjar, S.M. Alam, R. Dham and Q. Zaman Qumaruzaman, Biopharm. Drug Dispos., 21, 205 (2000).
- http://reference.medscape.com/drug/ceftin-zinacef-cefuroxime-342500.
- M. Sasinoska-Motyl, I.W. Wisniewska and I. Gumulka, Acta Pol. Pharm., 52, 391 (1995).
- R.D. Foord, Antimicrob. Agents Chemother., 9, 741 (1976).
- M.R. Sengar, S.V. Gandhi, U.P. Patil and V.S. Rajmane, Int. J. Chem. Tech. Res., 1, 1105 (2009).
- A. Szlagowska, M. Kaza and P.J. Rudzki, Acta Polon. Pharm. Drug Res., 67, 677 (2010).
- G. Piva, D. Farin, I .Gozlan and R. Kitzes-Cohen, Chromatographia, 51, 154 (2000).
- P. Jain, M. Patel and S. Surana, Int. J. Drug Develop. Res., 3, 318 (2011).
- S. Shelk, S. Dongre, A. Rathi, D. Dhamecha, S. Maria and M.H.G. Dehghan, Asian J. Res. Chem., 2, 222 (2009).
- M.D. Game, D.M. Sakarkar, K.B. Gabhane and K.K. Tapar, Int. J. Chem. Tech. Res., 2, 1259 (2010).
- M.S. Elazazy and A. Shalaby, E-J. Chem., 9, 2261 (2012).
- G. Pajchel and S. Tyski, J. Chromatogr. A, 895, 27 (2000).
- K.R. Sireesha, D.V. Mhaske, S.S. Kadam and S.R. Dhaneshwar, Indian J. Pharm. Sci., 66, 278 (2004).
- C.-C. Mondea, L. Vlase, A. Gyéresi and M. Bojita, Farmacia, 58, 408 (2010).
- C.J. Briscoe, M.R. Stiles and D.S. Hage, J. Pharm. Biomed. Anal., 44, 484 (2007).
References
C.R. Gelman, B.H. Rumakc and T.A. Hutchinson; Product Information, Ceftin®, Cefuroxime Axetil. Glaxo Inc., Research Triangle Park, NC, USA, In: L DRUGEX® System; Micromedex Inc.: Englewood, CO, USA (1999).
C. Dollery, Therapeutic Drugs, Churchill Livingstone, London, U.K., edn 2 (1999).
Y.Y. Zhang, P.J. Wu and Q. Zhang, Zhonghua NeiKe ZaZhi, 28, 340 (1989).
M.S. Al-Said, K.I. Al-Khamis, E.M. Niazy, Y.M. El-Sayed, K.A. Al-Rashood, S. Al-Bella, M.A. Al-Yamani, A. Al-Najjar, S.M. Alam, R. Dham and Q. Zaman Qumaruzaman, Biopharm. Drug Dispos., 21, 205 (2000).
http://reference.medscape.com/drug/ceftin-zinacef-cefuroxime-342500.
M. Sasinoska-Motyl, I.W. Wisniewska and I. Gumulka, Acta Pol. Pharm., 52, 391 (1995).
R.D. Foord, Antimicrob. Agents Chemother., 9, 741 (1976).
M.R. Sengar, S.V. Gandhi, U.P. Patil and V.S. Rajmane, Int. J. Chem. Tech. Res., 1, 1105 (2009).
A. Szlagowska, M. Kaza and P.J. Rudzki, Acta Polon. Pharm. Drug Res., 67, 677 (2010).
G. Piva, D. Farin, I .Gozlan and R. Kitzes-Cohen, Chromatographia, 51, 154 (2000).
P. Jain, M. Patel and S. Surana, Int. J. Drug Develop. Res., 3, 318 (2011).
S. Shelk, S. Dongre, A. Rathi, D. Dhamecha, S. Maria and M.H.G. Dehghan, Asian J. Res. Chem., 2, 222 (2009).
M.D. Game, D.M. Sakarkar, K.B. Gabhane and K.K. Tapar, Int. J. Chem. Tech. Res., 2, 1259 (2010).
M.S. Elazazy and A. Shalaby, E-J. Chem., 9, 2261 (2012).
G. Pajchel and S. Tyski, J. Chromatogr. A, 895, 27 (2000).
K.R. Sireesha, D.V. Mhaske, S.S. Kadam and S.R. Dhaneshwar, Indian J. Pharm. Sci., 66, 278 (2004).
C.-C. Mondea, L. Vlase, A. Gyéresi and M. Bojita, Farmacia, 58, 408 (2010).
C.J. Briscoe, M.R. Stiles and D.S. Hage, J. Pharm. Biomed. Anal., 44, 484 (2007).