摘要
目的：建立测定注射用硫酸长春新碱含量的方法。方法：采用高效液相色谱法。色谱柱为Agilent HC-C8,流动相为1.67%二乙胺水溶液（用磷酸调pH至7.5）-甲醇（38∶62,V/V）,流速为1.0 ml/min,检测波长为297 nm,柱温为35℃,进样量为10μl。结果：硫酸长春新碱的检测质量浓度线性范围为0.032-3.2 mg/ml（r=0.999 9）;精密度、稳定性、重复性试验的RSD〈1%;平均回收率99.3%-101.7%,RSD=0.6%（n=9）。结论：该方法准确、可靠、灵敏度高,可用于测定注射用硫酸长春新碱的含量。
OBJECTIVE：To establish a method for the content determination of Vincristine sulfate for injection. METHODS： HPLC was performed on the column of Agilent HC-C8 with mobile phase of 1.67% Diethylamine aqueous solution （adjusted to pH 7.5 with phosphoric acid） -methanol （ 38 ： 62, V/V） at a flow rate of 1.0 ml/min, the detection wavelength was 297 nm, the column temperature was 35 ℃, and the injection volume was 10μl. RESULTS： The linear range of vincristine sulfate was 0.032-3.2 mg/ml （r=0.999 9） ; RSDs of precision, stability and reproducibility tests were lower than 1% ; recovery was 99.3% -101.7% （RSD= 0.6%, n=9）. CONCLUSIONS： The method is accurate, reliable and sensitive, and can be used for the content determination of Vincristine sulfate for injection.
出处
《中国药房》
CAS
北大核心
2016年第3期407-409,共3页
China Pharmacy
