A Stability-Indicating LC Assay and Degradation Behavior of Temozolomide Drug Substances
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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.
KeywordsColumn liquid chromatography Solution and mobile phase stability Forced degradation Validation Temozolomide
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.
- 2.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:S95Google Scholar
- 3.Intensive and Critical Care Nursing (2000) 16:59–60Google Scholar
- 6.International conference on harmonization October (1994), Text on Validation of Analytical Procedures Q2AGoogle Scholar
- 10.International conference on harmonization November (1996), Validation of analytical procedures methodology Q2BGoogle Scholar