An Improvement on Determination of the Related Substances in Vindesine Sulfate and Its Injection
硫酸长春地辛及其注射剂有关物质检查方法的改进

A new method for the analysis of related substances in vindesine sulfate and its injection to improve the ability of separation by RP-HPLC was established. The separation was achieved by applying a reversed-phase C18 column (150 mm x 4.6 mm i.d.) and a mixture of V(MeOH):V(buffer solution) = 70:30 as mobile phase. The buffer solution was an aqueous solution of volume fraction 1.5% diethylamine adjusted to pH 7.5 with phosphoric acid. The UV-detector was set at 267 nm. Four related substances were separated from vindesine within thirteen minutes. The tailing factor of the peak of vindesine is 1.00-1.05. The results showed that this method is more efficient for separating the related substances in vindesine sulfate than the conventional method.