Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF TEMOZOLOMIDE IN BULK

Swathimutyam Pallerla and Bala Prabhakar*

ABSTRACT

The present method describes the development of a validated RP-HPLC method for determination of Temozolamide in presence of its degradation products. The drug substance was subjected to stress conditions of acid, alkali, oxidative and photo degradation studies. Separation was carried out on a C-18 kromasil (ODS column 250 mm × 4.6 mm I.D.; particle size 5 μm) using 20:80 [Methanol: 0.5% glacial acetic acid] as mobile phase at a flow rate of 1.0 ml/min. UV detection was performed at 316 nm and the retention time was 3.98min. The method was validated with respect to specificity, selectivity, linearity, accuracy, precision, and robustness. The assay method was found to be linear in the range of 10 to 70 μg/ml with a correlation coefficient of 0.9999. LOD and LOQ were found that 1 μg/mL and 5μg/mL. The results showed that the developed RP-HPLC method is suitable for determination of Temozolamide in bulk and the method was fast, simple, accurate, and precise. Validation of this method was accomplished, with results meeting all requirements. The developed HPLC method can be used for routine quality control tests.

Keywords: HPLC method development, forced degradation studies, accuracy, linearity, precision, robustness.