Copyright (c) 2018 AJC
This work is licensed under a Creative Commons Attribution 4.0 International License.
A Stability Indicating UPLC Method for Determination of Temozolomide and its Related Substances in Bulk and Finished Dosage Forms
Corresponding Author(s) : Ramu Ivaturi
Asian Journal of Chemistry,
Vol. 30 No. 9 (2018): Vol 30 Issue 9
Abstract
A simple, rapid, sensitive and stability indicating UPLC method has been developed for the quantitative estimation of temozolomide and its impurities in bulk and pharmaceutical dosage. The separation of temozolomide and its impurities was achieved by using Acquity UPLC BEH C18-50 × 2.1 mm, 1.7 μm column maintained at 30 °C with mobile phase consisting of 0.1 % formic acid in water, pH adjusted to 2.8 and acetonitrile in a gradient programme with 12 min run time. The mobile phase flow rate was 0.4 mL/min and the UV detection was carried out at a wavelength of 270 nm. The developed method was able to separate all the process related impurities and degradants of temozolomide with proper separation and also the proposed method was mass compatible. The stability indicating power of the method was verified by performing the forced degradation studies on temozolomide using 0.1 N HCl, 0.1 N NaOH, 3 % hydrogen peroxide, photolytic and thermal degradation studies. The proposed method was validated for specificity, linearity, accuracy, precision, robustness and ruggedness parameters in accordance with ICH guidelines. The validated method can be used for the routine as well as stability analysis in the quality control laboratories.
Keywords
Download Citation
Endnote/Zotero/Mendeley (RIS)BibTeX
- H.S. Friedman, T. Kerby and H. Calvert, Cancer Res., 6, 2585 (2000).
- S. Ostermann, C. Csajka, T. Buclin, S. Leyvraz, F. Lejeune, L.A. Decosterd and S. Roger, Clin. Cancer Res., 10, 3728 (2004); https://doi.org/10.1158/1078-0432.CCR-03-0807.
- E.S. Newlands, M.F. Stevens, S.R. Wedge, R.T. Wheelhouse and C. Brock, Cancer Treat. Rev., 23, 35 (1997); https://doi.org/10.1016/S0305-7372(97)90019-0.
- W.K. Yung, M.D. Prados, R. Yaya-Tur, S.S. Rosenfeld, M. Brada, H.S. Friedman, R. Albright, J. Olson, S.M. Chang, A.M. O’Neill, A.H. Friedman, J. Bruner, N. Yue, M. Dugan, S. Zaknoen and V.A. Levin, J. Clin. Oncol., 17, 2762 (1999); https://doi.org/10.1200/JCO.1999.17.9.2762.
- B.J. Denny, R.T. Wheelhouse, M.F.G. Stevens, L.L.H. Tsang and J.A. Slack, Biochemistry, 33, 9045 (1994); https://doi.org/10.1021/bi00197a003.
- B.D. Diez, P. Statkevich, Y. Zhu, M.A. Abutarif, F. Xuan, B. Kantesaria, D. Cutler, M. Cantillon, M. Schwarz, M.G. Pallotta and F.H. Ottaviano, Cancer Chemother. Pharmacol., 65, 727 (2010); https://doi.org/10.1007/s00280-009-1078-6.
- M.V. Matsko, Vopr. Onkol., 58, 425 (2012).
- R. Stupp and E. Newlands, Semin. Oncol., 28, 19 (2001); https://doi.org/10.1016/S0093-7754(01)90067-3.
- United States Pharmacopeia: USP-36: 5307-5308.
- British Pharmacopeia: ph. Eur. monograph- 2780.
- F. Shen, L.A. Decosterd, M. Gander, S. Leyvraz, J. Biollaz and F. Lejeune, J. Chromatogr. B Biomed. Appl., 667, 291 (1995); https://doi.org/10.1016/0378-4347(95)00040-P.
- E. Gilant, M. Kaza, A. Szlagowska, K. Serafin-Byczak and P.J. Rudzki, Acta Pol. Pharm., 69, 1347 (2012).
- H. Kim, P. Likhari, D. Parker, P. Statkevich, A. Marco, C.C. Lin and A.A. Nomeir, J. Pharm. Biomed. Anal., 24, 461 (2001); https://doi.org/10.1016/S0731-7085(00)00466-0.
- L. Goldwirt, N. Zahr, R. Farinotti and C. Fernandez, Biomed. Chromatogr., 27, 889 (2013); https://doi.org/10.1002/bmc.2877.
- M. Andrasi, R. Bustos, A. Gaspar, F.A. Gomez and A. Klekner, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 878, 1801 (2010); https://doi.org/10.1016/j.jchromb.2010.05.008.
- C.J. Peer, L. Ronner, L. Rodgers, C.M.L. McCully, K.E. Warren and W.D. Figg, Separations, 3, 4 (2016); https://doi.org/10.3390/chromatography3010004.
- A.A. Razak, S.K. Masthanamma, B. Omshanthi, V. Suresh and P. Obulamma, Int. J. Pharm. Sci. Res., 4, 1419 (2013).
- International Conference of Harmonisation-ICH Validation of Analytical Procedures: Text and Methodology Q2 (R1), Harmonised Tripartite Guideline (2005).
- L.H. Swift and R.M. Golsteyn, Int. J. Mol. Sci., 15, 3403 (2014); https://doi.org/10.3390/ijms15033403.
- N.J. Babu, L.S. Reddy, S. Aitipamula and A. Nangia, Chem. Asian J., 3, 1122 (2008); https://doi.org/10.1002/asia.200800070.
- www.ema.europe-Assessment report for Temozolomide procedure No: EMEA/H/C/1125.
- FDA: Guidance for Industry, Analytical Procedures and Methods Validation, August (2000).
References
H.S. Friedman, T. Kerby and H. Calvert, Cancer Res., 6, 2585 (2000).
S. Ostermann, C. Csajka, T. Buclin, S. Leyvraz, F. Lejeune, L.A. Decosterd and S. Roger, Clin. Cancer Res., 10, 3728 (2004); https://doi.org/10.1158/1078-0432.CCR-03-0807.
E.S. Newlands, M.F. Stevens, S.R. Wedge, R.T. Wheelhouse and C. Brock, Cancer Treat. Rev., 23, 35 (1997); https://doi.org/10.1016/S0305-7372(97)90019-0.
W.K. Yung, M.D. Prados, R. Yaya-Tur, S.S. Rosenfeld, M. Brada, H.S. Friedman, R. Albright, J. Olson, S.M. Chang, A.M. O’Neill, A.H. Friedman, J. Bruner, N. Yue, M. Dugan, S. Zaknoen and V.A. Levin, J. Clin. Oncol., 17, 2762 (1999); https://doi.org/10.1200/JCO.1999.17.9.2762.
B.J. Denny, R.T. Wheelhouse, M.F.G. Stevens, L.L.H. Tsang and J.A. Slack, Biochemistry, 33, 9045 (1994); https://doi.org/10.1021/bi00197a003.
B.D. Diez, P. Statkevich, Y. Zhu, M.A. Abutarif, F. Xuan, B. Kantesaria, D. Cutler, M. Cantillon, M. Schwarz, M.G. Pallotta and F.H. Ottaviano, Cancer Chemother. Pharmacol., 65, 727 (2010); https://doi.org/10.1007/s00280-009-1078-6.
M.V. Matsko, Vopr. Onkol., 58, 425 (2012).
R. Stupp and E. Newlands, Semin. Oncol., 28, 19 (2001); https://doi.org/10.1016/S0093-7754(01)90067-3.
United States Pharmacopeia: USP-36: 5307-5308.
British Pharmacopeia: ph. Eur. monograph- 2780.
F. Shen, L.A. Decosterd, M. Gander, S. Leyvraz, J. Biollaz and F. Lejeune, J. Chromatogr. B Biomed. Appl., 667, 291 (1995); https://doi.org/10.1016/0378-4347(95)00040-P.
E. Gilant, M. Kaza, A. Szlagowska, K. Serafin-Byczak and P.J. Rudzki, Acta Pol. Pharm., 69, 1347 (2012).
H. Kim, P. Likhari, D. Parker, P. Statkevich, A. Marco, C.C. Lin and A.A. Nomeir, J. Pharm. Biomed. Anal., 24, 461 (2001); https://doi.org/10.1016/S0731-7085(00)00466-0.
L. Goldwirt, N. Zahr, R. Farinotti and C. Fernandez, Biomed. Chromatogr., 27, 889 (2013); https://doi.org/10.1002/bmc.2877.
M. Andrasi, R. Bustos, A. Gaspar, F.A. Gomez and A. Klekner, J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 878, 1801 (2010); https://doi.org/10.1016/j.jchromb.2010.05.008.
C.J. Peer, L. Ronner, L. Rodgers, C.M.L. McCully, K.E. Warren and W.D. Figg, Separations, 3, 4 (2016); https://doi.org/10.3390/chromatography3010004.
A.A. Razak, S.K. Masthanamma, B. Omshanthi, V. Suresh and P. Obulamma, Int. J. Pharm. Sci. Res., 4, 1419 (2013).
International Conference of Harmonisation-ICH Validation of Analytical Procedures: Text and Methodology Q2 (R1), Harmonised Tripartite Guideline (2005).
L.H. Swift and R.M. Golsteyn, Int. J. Mol. Sci., 15, 3403 (2014); https://doi.org/10.3390/ijms15033403.
N.J. Babu, L.S. Reddy, S. Aitipamula and A. Nangia, Chem. Asian J., 3, 1122 (2008); https://doi.org/10.1002/asia.200800070.
www.ema.europe-Assessment report for Temozolomide procedure No: EMEA/H/C/1125.
FDA: Guidance for Industry, Analytical Procedures and Methods Validation, August (2000).