摘要
奥沙利铂属于铂类广谱抗肿瘤药,广泛应用于临床治疗及科学研究中。目前针对奥沙利铂制剂的含量测定方法多数为高效液相色谱法(high performance liquid chromatography,HPLC),存在分析过程耗时较长等问题。为了更高效地测定制剂中奥沙利铂的含量,建立了以UPLC为基础的药物含量测定方法,并测定了奥沙利铂-PLGA缓释薄膜中的药物含量。采用Shim-pad GIST-HP-C18色谱柱(50 mm×2.1 mm,3μm),以乙腈-水(1∶99)为流动相,用磷酸调节溶液至pH=3,流速0.5 mL/min,检测波长254 nm,柱温40℃,进样量10μL,外标法定量。结果表明,奥沙利铂质量浓度分别在1.25~100μg/mL(R=1.000)呈良好线性关系。平均回收率(n=9)为99.93%,相对标准偏差(relative standard deviation,RSD)为1.3%。本文所建立的方法准确、简便、快速,重复性好,可用于PLGA缓释薄膜中奥沙利铂的含量测定。
Oxaliplatin is a broad-spectrum platinum antitumor drug that has been widely used in clinical practice and scientific research.At present,the drug content determination methods for oxaliplatin are mostly based on high performance liquid chromatography(HPLC).However,they are usually very time-consuming.In order to increase the efficiency of analysis process,a UPLC method was established and the content of oxaliplatin in PLGA sustained-release films was determined.Shim-pad GIST-HP-C18 column(50 mm×2.1 mm,3μm)was used,acetonitrile-water(1∶99)was used as the mobile phase,the solution was adjusted to pH=3 with phosphoric acid,and the flow rate was 0.5 mL/min,detection wavelength was 254 nm,colum temperature was 40℃,injection volume was 10μL,and the external standard method was used for quantification.The results show that the assay was validated in the concentration range of 1.25~100μg/mL(R=1.000).The average recovery rate(n=9)was 99.93%,relative standard deviation(RSD)=1.3%.It can be seen that the established UPLC method is accurate,simple,rapid and reproducible,and can be used for the determination of oxaliplatin in PLGA sustained-release film.
作者
冯数橙
蔡啟梅
王涛
申辽
高春生
FENG Shu-cheng;CAI Qi-mei;WANG Tao;SHEN Liao;GAO Chun-sheng(Institute of Pharmacology and Toxicology,Academy of Military Medical Sciences,Beijing 100850,China)
出处
《科学技术与工程》
北大核心
2022年第31期13717-13722,共6页
Science Technology and Engineering
基金
国家自然科学基金青年科学基金(82001936)。
