For the measurement and quantification of Dacarbazine, a rapid, simple, sensitive, and reliable RPHPLC technique using a Waters HPLC System with PDA detection was designed and validated. In this work, Dacarbazine was subjected to different stress conditions mentioned by international conference on Harmonization. A stability indicating method was developed for the analysis of the drug in the presence of its degradation products. Chromatography was carried out on an Altimal ods 150 mmX4.6 mm 5 µm column with a rate of flow 1.0 ml/min and an effluent of 323 nm using filtered and mixed Degassed 0.1% OPA buffer: Acetonitrile (90:10) as a mobile phase, The buffer pH was maintained at 5 and the temperature was ambient i.e., 300c. Dacarbazine Retention time is 2.717 minutes. Even the percentage purity of the drug was observed at 99.99%. Later the system suitability criteria i.e., theoretical plates, tailing factor, and Asymmetry values for Dacarbazine was revealed at 4484, 1.10 and 1.101 respectively. Linearity range was observed well at 25-150 µg/mL concentration series, Linearity test Correlation Coefficient was found to be 0.999 for the compound. and then the %mean recovery for the drug at 50%, 100% and 150% were 100.16, 99.85 and 100.32 correspondingly, for %RSD precision that is intraday it was 0.53% and Inter-day it was 0.83%, The values of LOD and LOQ obtained from Dacarbazine was 0.17 μg/ml and 0.52μg/ml. The method was simple and economical that can be applied successfully for simultaneous estimation of Stability Studies of Dacarbazine.

Method Development, Validation, Dacarbazine, Degradation, stability indicating, RP-HPLC