Validated Environmentally Friendly Chromatographic Determinations of Dacarbazine and its Related Substances.

Abstract

Sensitive and specific eco-friendly chromatographic approaches were developed to quantitatively determine Dacarbazine along with its United States Pharmacopeia (USP) related impurities simultaneously. Method I was reveresed phase HPLC (RP-HPLC) by which separation of the ternary mixture was achieved. Zorbax Eclipse Plus octadecyl column as stationary phase, a mobile phase formed of double distilled water and methanol at a ratio of (70: 30, v/v) and 0.6 mL/min as a flow rate were used for isocratic separation. Ultra violet (UV) detection was adjusted at 230 nm. Method II is high performance thin layer chromatography (HPTLC), where the separation was performed on silica gel plates using green developing system composed of butanol: ethyl acetate: 0.05 M ammonium acetate (2: 4: 0.4, by volume) with UV detection at 280 nm. Green behavior of the developed techniques was evaluated. The International Council for Harmonisation (ICH) guidelines were considered for the proposed approaches validation. Moreover, Dacarbazine was successfully determined in Dacarbazine medac® powder for injection by the proposed techniques. No significant difference aroused between the results of the developed techniques and the results aroused from the official USP spectrophotometric method. Furthermore, the proposed methods had the merits of being more friendly towards the environment, sensitive and time saver than other reported HPLC methods.