Stress degradation study of two oral antidiabetics, gliclazide and glipizide, and chemical analysis by LC and LC/MS methods

• Authors: Anna Gumieniczek , Anna Berecka , Rafał Pietraś , Marek Ślebioda
• Languages of publication: EN

Abstracts

EN

Kinetic study of degradation of two oral antidiabetics, gliclazide and glipizide, was performed using new HPLC method which was validated in terms of selectivity, sensitivity, linearity, precision and accuracy. The stress degradation was performed in 0.2 M HCl, 0.2 M NaOH as well as in acetate and phosphate buffers over the pH range 3.8–8.3 at 30 and 70°C. In strong acidic and alkaline media gliclazide was almost fully degraded while glipizide showed much higher stability. Generally, degradation processes of gliclazide and glipizide were observed as the first order reactions while the rates of decomposition for both drugs were smallest at pH 8.3. The samples of gliclazide and glipizide stressed in strong acid and alkali at 70°C were additionally analyzed using an LC/MS method and some products of decomposition were detected and identified. It was concluded that glipizide was more resistant to very high or very low pH and would have higher stability compared to gliclazide. Such comparisons have not been performed so far for these valuable drugs. Additional LC/MS study showed that during decomposition of sulfonylureas, different degradation pathways were possible. [...]

Keywords

EN

Gliclazide and glipizide; Stress degradation; Kinetics; LC and LC/MS methods

• Publisher: De Gruyter Open
• Journal: Open Chemistry
• Year: 2014
• Volume: 12
• Issue: 1
• Pages: 80-89

Dates

published

1 - 1 - 2014

online

27 - 10 - 2013

Contributors

author

Anna Gumieniczek

• Department of Medicinal Chemistry, Faculty of Pharmacy, Medical University in Lublin, 20-090, Lublin, Poland

author

Anna Berecka

• Department of Medicinal Chemistry, Faculty of Pharmacy, Medical University in Lublin, 20-090, Lublin, Poland

author

Rafał Pietraś

• Department of Medicinal Chemistry, Faculty of Pharmacy, Medical University in Lublin, 20-090, Lublin, Poland

author

Marek Ślebioda

• Perlan Technologies Polska Sp. z o.o., 02-785, Warsaw, Poland

References

• [1] M. Gandhimathi, K. Anandakumar, A. Cheriyan, T.K. Ravi, Indian J. Pharm. Sci. 65, 530 (2003)
• [2] N.M. Mansoory, A. Jain, Int. J. Pharm. Pharm. Sci. 4, 72 (2012)
• [3] S. Pawar, G.A. Meshram, M. Phadke, R.K. Jadhav, Indian Drugs 46, 69 (2009)
• [4] B.V.V. Ravikumar, A.K. Patnaik, S.K. Raul, N.N. Rao, J. App. Pharm. Sci. 3, 59 (2013)
• [5] R.B. Udaykumar, A.P. Nikalje, African J. Pharm. Pharmacol. 5, 1331 (2011) [Crossref]
• [6] A. Dubey, I.C. Shukla, J. Indian Chem. Soc. 81, 84 (2004)
• [7] S. Goyal, A. Gupta, N. Bhatt, R. Rani, Int. J. PharmTech Res. 5, 183 (2013)
• [8] M. Karpillai, S. Dhangar, Research J. Pharm. and Tech. 4, 949 (2011)
• [9] S.S. Zarapkar, S.K. Kulkarni, N.S. Kanyawar, Indian Drugs, 38, 535 (2001)
• [10] J. Ayyappan, P. Umapathi, S. Darling Quine, Int. J. Pharm. Pharm. Sci. 3, 371 (2011)
• [11] J. Shaodong, W.J. Lee, J.W. Ee, J.H. Park, S.W. Kwon, J. Lee, J. Pharm. Biomed. Anal. 51, 973 (2010) http://dx.doi.org/10.1016/j.jpba.2009.10.019[Crossref]
• [12] M. Vasudevan, J. Ravi, S. Ravisankar, B. Suresh, J. Pharm. Biomed. Anal. 25, 77 (2001) http://dx.doi.org/10.1016/S0731-7085(00)00493-3[Crossref]
• [13] R. Nadkarni Deepali, R.N. Merchant, M. Sundaresan, A.M. Bhagwat, Indian Drugs 34, 650 (1997)
• [14] B.L. Kolte, B.B. Raut, A.A. Deo, M.A. Bagool, D.B. Shinde, J. Liq. Chromatogr. Related Technol. 26, 1117 (2003) http://dx.doi.org/10.1081/JLC-120020098[Crossref]
• [15] J. Krzek, M. Dąbrowska, U. Hubicka, J. Planar Chromatogr. 14, 183 (2001)
• [16] N.M. El Kousy, Mikrochim. Acta 128, 65 (1998) http://dx.doi.org/10.1007/BF01242191[Crossref]
• [17] A. Gumieniczek, A. Berecka, J. Planar Chromatogr. 23, 1 (2010) http://dx.doi.org/10.1556/JPC.23.2010.2.8[Crossref]
• [18] M. Albu, A. Medvedovici, F. Tache, Anal. Lett. 43, 1162 (2010) http://dx.doi.org/10.1080/00032710903518591[Crossref]
• [19] A. Gumieniczek, A. Berecka, Ł. Komsta, J. AOAC Int. 93, 1086 (2010)
• [20] A. Gumieniczek, A. Berecka, H. Hopkała, J. AOAC Int. 89, 319 (2006)
• [21] G. Bansal, M. Singh, K.C. Jindal, Chromatographia 66, 751 (2007) http://dx.doi.org/10.1365/s10337-007-0394-4[Crossref]
• [22] G. Bansal, J. AOAC Int. 94, 523 (2011)
• [23] G. Bansal, M. Singh, K.C. Jindal, S. Singh, J. Liq. Chromatogr. Related Technol. 31, 2174 (2008) http://dx.doi.org/10.1080/10826070802225585[Crossref]
• [24] G. Bansal, M. Singh, K.C. Jindal, S. Singh, J. Chromatogr. Sci. 46, 510 (2008) http://dx.doi.org/10.1093/chromsci/46.6.510[Crossref]
• [25] W. Pang, H. Yang, Z. Wu, M. Huang, J. Hu, Chromatographia 70, 1353 (2009) http://dx.doi.org/10.1365/s10337-009-1344-0[Crossref]
• [26] A.K. Sarmah, J. Sabadie, J. Agric. Food Chem. 50, 6253 (2002) http://dx.doi.org/10.1021/jf025575p[Crossref]
• [27] G. Bansal, M. Singh, K.C. Jindal, S. Singh, J. Pharm. Biomed. Anal. 48, 788 (2008) http://dx.doi.org/10.1016/j.jpba.2008.08.003[Crossref]

Identifiers

DOI

10.2478/s11532-013-0355-8