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目的建立注射用奥沙利铂含量及有关物质的HPLC方法。方法含量和有关物质测定以十八烷基硅烷键合硅胶作为填充剂Zorbax Rx-C18(4.6 mm×250 mm)5μm,以磷酸溶液(取10%磷酸溶液0.6 m L,加水稀释至1 000 m L,用氢氧化钠溶液或磷酸调节pH值至3.0)—乙腈=99∶1为流动相,流速0.8 m L·min~(-1),检测波长209 nm,进样量20μL。结果奥沙利铂在6~16×10-3g·L~(-1)浓度范围内线性关系良好,检测限为0.02%,回收率为100.55%(RSD=0.46%),测定样品含量为99.8%,有关物质均小于0.5%。结论该方法快速,专属性强,灵敏度高,重现性好,可作为注射用奥沙利铂的含量及有关物质的检测方法。
OBJECTIVE To establish HPLC method for the determination of oxaliplatin in injection and related substances. Method content and related substances Determination of octadecylsilane bonded silica as a filler Zorbax Rx-C18 (4.6 mm × 250 mm) 5μm, phosphoric acid solution (take 10% phosphoric acid solution 0.6 m L, diluted with water to 1000 m L, adjusting the pH value to 3.0 with acetonitrile or phosphoric acid. The mobile phase consisted of acetonitrile and 99:1. The flow rate was 0.8 m L · min -1. The detection wavelength was 209 nm and the injection volume was 20 μL. Results Oxaliplatin had a good linearity in the concentration range of 6-16 × 10-3g · L -1 with a detection limit of 0.02% and a recovery of 100.55% (RSD = 0.46%). The content of the sample was 99.8 %, The relevant substances are less than 0.5%. Conclusion The method is rapid, specific, sensitive and reproducible. It can be used as a method for the determination of oxaliplatin and related substances in injection.