Validation of a sensitive and robust reversed phase-HPLC method for determination of temozolomide

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%.