| 陈传喜,杨志勇,袁红,等.HPLC测定注射用奥沙利铂的含量及有关物质[J].安徽医药,2016,20(3):454-457. |
| HPLC测定注射用奥沙利铂的含量及有关物质 |
| Determination of content and related substances of Oxaliplatin for Injection by HPLC |
| 投稿时间：2015-10-23 |
| DOI： |
| 中文关键词: 注射用奥沙利铂 HPLC法 含量 有关物质 |
| 英文关键词: oxaliplatin for injection HPLC content related substance |
| 基金项目: |
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| 摘要点击次数: 2948 |
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| 中文摘要: |
| 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)5 μm,以磷酸溶液(取10%磷酸溶液0.6 mL,加水稀释至1 000 mL,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 mL·min-1,检测波长209 nm,进样量20 μL。 结果 奥沙利铂在6～16×10-3 g·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。 |
| 英文摘要: |
| 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 6～16×10-3 g·L-1. The limits of detection 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. |
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