摘要
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 an HPLC method to determine the oxaliplatin content and the related substances of oxaliplatin for injection.Methods The chromatographic separation was performed on Zorbax Rx -C18 （4.6 mm ×250 mm,5 μm）that was made by alkyl -bonded silica gels,phosphoric acid solution（10% phosphoric acid solution 0.6 mL,diluted with water to 1 000 mL,pH adjusted to 3.0 with sodium hydroxide solution or phosphoric acid）- acetonitrile =99 ∶1;the flow rate was 0.8 mL·min^-1 ;the detection wavelength was 209 nm;the sample size was 20 μL.Results The linear of oxaliplatin was 6 -16 ×0^-3 g·L^-1 .The limits of de-tection was 0.02%.The average recovery was 100.55%（RSD =0.46%）.Determination of the sample average content was 99.8%, and the related substance was less than 0.5%.Conclusions The method is rapid,specific,sensitive,and well repeatable,which can be used to determine the content of oxaliplatin for injection and its related substances.
出处
《安徽医药》
CAS
2016年第3期454-457,共4页
Anhui Medical and Pharmaceutical Journal
