A Facile RP-HPLC Strategy for Sensitive Detection and Stability Study of Dacarbazine in API and in Pharmaceutical Dosage Form

Abstract

The current work reflects a simple, robustic, accurate, precise, rapid and stable RP-HPLC method and validates it for quantifying Dacarbazine in API and its parenteral preparation. it is based on identification of drug in reversed phase mode using HPLC. The mobile phase consist of mixture of 960ml of 0.5% v/v glacial acetic acid, added with 0.94g of n-hexane sulphonic acid sodium salt monohydrated and 40 ml of methanol. The drug was detected at 329nm wavelength. The method was later validated as per guidelines proposed by ICH. The drug was exposed to variable stressed conditions and was analyzed by proposed method. The chromatogram reflects no inference from degradative product, excipients or impurities. However, drug under various stress degradation conditions reflects that it is highly susceptible to oxidative condition as 21.89% of drug was degraded. In acidic and alkaline conditions, the drug was degraded by 14.96% and 11.31% respectively, while thermal and photolytic condition causes least degradation, i.e. 1.08% and 1.15% respectively. The proposed method was found to be accurate, reproducible and linear. Thus can be applicable for the quantitative estimation of Dacarbazine and can be successfully applied in the quality control of API and its parenteral preparation.