Abstract
This study deals with a stability indicating HPLC reverse phase method for quantitative determination of temozolomide. A chromatographic separation was achieved on an Inertsil ODS 3V, 250 × 4.6 mm ID, 5 μm column using mobile phase A (buffer 5 mL glacial acetic acid in 1,000 mL of Milli Q water ) and mobile phase B (methanol). Forced degradation studies were performed on bulk sample of temozolomide using acid (0.5 N hydrochloric acid), base (0.5 N sodium hydroxide), oxidation (10% v/v hydrogen peroxide), heat (60 °C) and UV light (254 nm). Degradation of the drug substance was observed in base hydrolysis and oxidation. Degradation product formed under these conditions was found to be Imp-A. When the stress samples were assayed, the mass balance was close to 99.5%. The sample solution was stable up to 48 h at 5 °C and mobile phase was found to be stable up to 48 h at 25 °C. The developed method was validated with respect to linearity, accuracy, precision, robustness and forced degradation studies prove the stability indicating power of the method.
Similar content being viewed by others
References
Ueno T, Ko SH, Grubbs E, Pruitt SK, Friedman HS, Tyler DS (2004) Am J Surg 188:532–537
Basso U, Ermani M, Reni M, Vastola F, Tosoni A, Pasetto LM, Coria B, Cacciacarne M, Sala F, Brandes AA (2003) Eur J Cancer 1:S95
Intensive and Critical Care Nursing (2000) 16:59–60
Siker ML, Chakravarti A, Mehta MP (2006) Crit Rev Oncol/Hematol 60:99–111
Giorgio CG, Giuffrida D, Pappalardo A, Russo A, Santini D, Salice P, Blanco G, Castorina S, Failla G, Bordonaro R (2005) Lung Cancer 50:247–254
International conference on harmonization October (1994), Text on Validation of Analytical Procedures Q2A
Kim H, Likhari P, Parker D, Statkevich P, Marco A, Lin CC, Nomeir AA (2001) J Pharm Biomed Anal 24:461–468
Chowdhury SK, Laudicina D, Blumenkrantz N, Wirth M, Alton KB (1999) J Pharm Biomed Anal 19:659–668
Kim HK, Lin CC, Parker D, Veals J, Lim J, Likhari P, Statkevich P, Marco A, Nomeir AA (1997) J Chromatogr B: Biomed Sci Appl 703:225–233
International conference on harmonization November (1996), Validation of analytical procedures methodology Q2B
Acknowledgments
The authors wish to thank the management of Dr. Reddy’s group for supporting this work. Authors wish to acknowledge the process research group for providing the samples for our research. We would also like to thank colleagues in the separation science division of the Analytical Research of High Potent Active Pharmaceutical Ingredients for their co-operation in carrying out this work.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Saravanan, G., Ravikumar, M., Jadhav, M.J. et al. A Stability-Indicating LC Assay and Degradation Behavior of Temozolomide Drug Substances. Chroma 66, 291–294 (2007). https://doi.org/10.1365/s10337-007-0306-7
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1365/s10337-007-0306-7