【摘要】：目的:建立甲啶鉑高效液相色譜分析方法,采用該方法測(cè)定甲啶鉑原料藥的純度,并研究甲啶鉑在酸堿、氧化還原環(huán)境中的穩(wěn)定性。方法:采用Waters XTerra PR C18(250 mm×4.6 mm,5μm)色譜柱,以15%乙腈水溶液為流動(dòng)相等度洗脫,流速1.0 m L·min-1,二極管陣列檢測(cè)器(PDA)于200~400 nm內(nèi)檢測(cè)含量并分析純度。在甲啶鉑溶液中添加HCl、Na OH、H2O2和Na HSO3,采用高效液相色譜法測(cè)定含量,考察甲啶鉑在酸堿、氧化還原環(huán)境中的穩(wěn)定性。結(jié)果:此方法可以快速靈敏地測(cè)定甲啶鉑含量,甲啶鉑質(zhì)量濃度在0.02~0.2 mg·m L-1范圍內(nèi)線性相關(guān)(R20.999 9),檢測(cè)限和定量限分別為0.094 ng和0.22ng。此方法可以同時(shí)將甲啶鉑與順鉑、三氯氨鉑酸鉀和順式-二氯-氨、(3-甲基吡啶)合鉑(Ⅱ)等雜質(zhì)有效分離。純度分析表明,試制的3批甲啶鉑原料藥純度高。穩(wěn)定性試驗(yàn)顯示,堿性及氧化環(huán)境對(duì)甲啶鉑具有很強(qiáng)的破壞作用。結(jié)論:此方法可用于甲啶鉑原料藥及其制備過(guò)程中的檢測(cè)和監(jiān)控,在甲啶鉑原料藥保存和制劑研究過(guò)程中應(yīng)避免與堿性和氧化性物質(zhì)接觸。
[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，

本文編號(hào)：2130837