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本文报道在剂型确定前,用反相高效液相色谱仪,以1-戊烷基磺酸钠为离子对流动相,测定硫酸长春新碱(VCR)的含量。本法快速且简便。硫酸长春碱(VLB)以及VCR 的降解产物对测定无干扰。制剂中可能存在的几种赋形剂,如缓冲剂、乳糖(1mg/ml)、甘露醇(1mg/ml)、氯化钠、苄醇、对羟基苯甲酸酯类(Para-bens),在上述系统中均不干扰硫酸长春新碱的测定。本法在正常注入浓度的10~200%之间呈线性关系,测定的精密度(相对2σ)为±1.6%。样品回收率平均为99.7%。
This article reports the determination of vincristine sulfate (VCR) before the formulation was determined by reversed-phase high performance liquid chromatography with sodium 1-pentylsulfonate as mobile phase. This law is quick and easy. Vinblastine sulfate (VLB) and degradation products of VCR did not interfere with the assay. Several excipients that may be present in the formulation such as buffers, lactose (1 mg / ml), mannitol (1 mg / ml), sodium chloride, benzyl alcohol, para- bens, None of the above systems interfere with the determination of vincristine sulfate. This method has a linear relationship between 10% and 200% of the normal injection concentration with a precision of ± 1.6% (relative 2σ). The average recovery rate was 99.7%.