甲啶铂原料药的高效液相色谱分析及其稳定性研究

发布时间：2018-07-17 20:25

【摘要】：目的:建立甲啶铂高效液相色谱分析方法,采用该方法测定甲啶铂原料药的纯度,并研究甲啶铂在酸碱、氧化还原环境中的稳定性。方法:采用Waters XTerra PR C18(250 mm×4.6 mm,5μm)色谱柱,以15%乙腈水溶液为流动相等度洗脱,流速1.0 m L·min-1,二极管阵列检测器(PDA)于200~400 nm内检测含量并分析纯度。在甲啶铂溶液中添加HCl、Na OH、H2O2和Na HSO3,采用高效液相色谱法测定含量,考察甲啶铂在酸碱、氧化还原环境中的稳定性。结果:此方法可以快速灵敏地测定甲啶铂含量,甲啶铂质量浓度在0.02~0.2 mg·m L-1范围内线性相关(R20.999 9),检测限和定量限分别为0.094 ng和0.22ng。此方法可以同时将甲啶铂与顺铂、三氯氨铂酸钾和顺式-二氯-氨、(3-甲基吡啶)合铂(Ⅱ)等杂质有效分离。纯度分析表明,试制的3批甲啶铂原料药纯度高。稳定性试验显示,碱性及氧化环境对甲啶铂具有很强的破坏作用。结论:此方法可用于甲啶铂原料药及其制备过程中的检测和监控,在甲啶铂原料药保存和制剂研究过程中应避免与碱性和氧化性物质接触。
[Abstract]:Objective: to establish a high performance liquid chromatography method for the determination of the purity and stability of methaliplatin in acid-base, redox environment. Methods: a Waters XTerra PR C18 (250 mm 脳 4.6 mm) column was used. The flow rate was 1.0 mL 路min ~ (-1), and the purity was analyzed by diode array detector (PDA) at 200 nm. The content of HClOH H 2O 2 and Na HSO 3 was determined by high performance liquid chromatography (HPLC), and the stability of methaliplatin in acid base, redox environment was investigated. Results: this method can be used for the rapid and sensitive determination of triadidine platinum. The linear correlation (R20.999 9) was obtained in the range of 0.02 ~ (2) mg m ~ (-1). The detection limit and the quantitative limit were 0.094 ng and 0.22 ng 路mL ~ (-1), respectively. This method can also be used to effectively separate methylplatin from cisplatin, potassium trichloroaminoplatinate, cis-dichloro-ammonia, (3-methylpyridine) platinum (鈪，

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