Validation of a Sensitive and Robust Reversed Phase-HPLC Method for Determination of Temozolomide

Attari, Zenab and Kumar, Lalit and Rao, Mallikarjuna C and Koteshwara, KB (2016) Validation of a Sensitive and Robust Reversed Phase-HPLC Method for Determination of Temozolomide. Latin American Journal of Pharmacy, 35 (5). pp. 967-971. ISSN 2362-3853

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Abstract

SUMMARY. Temozolomide is a physiologically pH labile, alkylating agent used in glioblastoma multiforme.An attempt has been made to develop and validate a simple, sensitive, accurate, precise and robust HPLC method for quantification of temozolomide. Ammonium formate and acetonitrile combination used as mobile phase using BDS C18 column resulted in elution of temozolomide with retention time of 5.866 min. The various parameters, precision, accuracy and robustness of the method were evaluated. The % RSD of the parameters were acceptable (< 2 or/and 1%). The LOD and LOQ were found to be 13.13 and 39.81 ng/mL, respectively. The recovery of the drug was observed to be 99.97 to 100.93%.RESUMEN. La temozolomida es un agente alquilante fisiológicamente pH-lábil, utilizado en el tratamiento del glioblastoma multiforme. Se ha desarrollado y validado un método de HPLC sencillo, sensible, exacto, preciso y robusto para la cuantificación de la temozolomida. La combinación de formiato de amonio y acetonitrilo fue utilizada como fase móvil usando una columna BDS C18, lo que permitió la elución de temozolomida con un tiempo de retención de 5,866 min. Se evaluaron diferentes parámetros del método, tales como la precisión, la exactitud y la robustez. La RSD% de los parámetros fueron aceptables (<2 y/o 1%). El LOD y LOQ se encontró que eran 13,13 y 39,81 ng/mL, respectivamente. La recuperación de la droga fue del 99.97 al 100,93%.

Item Type: Article
Uncontrolled Keywords: Chromatogram; Limit of detection; Limit of quantitation; Precision; Robustness; Temozolomide
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutics
Pharmacy > MCOPS Manipal > Pharmacology
Depositing User: KMC Library
Date Deposited: 10 May 2016 12:11
Last Modified: 10 May 2016 12:11
URI: http://eprints.manipal.edu/id/eprint/146002

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