近红外荧光染料Cypate有关物质检测方法的建立及其体外光热转换效应  

Establishment of the method for the detection of related substances in the near infrared fluorescent dye Cypate and its photothermal conversion effect in vitro

作　　者：蔡亮亮 韩勇 沈凯 吴雯仪 朱永红[1] CAI Liang-liang;HAN Yong;SHEN Kai;WU Wen-yi;ZHU Yong-hong(Department of Pharmacy,Affiliated Hospital of Nantong University,Nantong 226001,China;Oncology of Department,Affiliated Hospital of Nantong University,Nantong 226001,China;SinopharmHolding Nantong Co.,Ltd,Nantong 226001,China)

机构地区：[1]南通大学附属医院药学部,南通226001 [2]南通大学附属医院肿瘤科,南通226001 [3]国药控股南通有限公司,南通226001

出　　处：《药物分析杂志》2021年第10期1757-1763,共7页Chinese Journal of Pharmaceutical Analysis

基　　金：国家自然科学基金项目(81900528);江苏省博士后科研资助计划项目(2020Z435)。

摘　　要：目的:建立近红外荧光染料Cypate有关物质检测方法,并进行其体外光热转换效应研究。方法:采用Luna-C_(18)(250 mm×4.6 mm,5μm)色谱柱,以0.01 mol·L^(-1)磷酸盐缓冲液(pH 2.5)为流动相A,乙腈为流动相B,梯度洗脱(0~2 min,30%B;2~25 min,30%B→52%B;25~40 min,52%B→60%B;40~55min,60%B→75%B;55~60 min,75%B;60~61 min,75%B→30%B;61~70 min,30%B),流速1.0 mL·min^(-1),检测波长220 nm,柱温30℃。Cypate的光热转换效应研究则用785 nm激光器照射样品5 min,每隔30 s记录溶液的温度。结果:Cypate峰与其相邻杂质峰最小分离度为1.80(>1.5),其他杂质峰之间最小分离度为1.38(>1.2);质量浓度在0.1~25.1μg·mL^(-1)范围内,与峰面积呈现良好的线性关系(r=0.9990);检测下限、定量下限分别为0.02、0.06μg·mL^(-1)。此外,在0~210 s内Cypate的光热转换效应呈现明显的浓度,时间依赖性。结论:该方法符合Cypate与杂质峰之间的分离度要求,适合Cypate的有关物质测定;Cypate的光热转换效应较好。Objective:To establish an HPLC method for the analysis of related substances in near infrared fluorescent dye Cypate and study its photothermal conversion effect in vitro.Methods:The Phenomenex Luna-C_(18) column(250 mm×4.6 mm,5μm)was used for separation with the mobile phase consisting of 0.01 mol·L^(-1)phosphate buffer(pH 2.5)(A)and acetonitrile(B)in gradient elution model.The gradient elution procedure was as follows:0-2 min,30%B;2-25 min,30%B→52%B;25-40 min,52%B→60%B;40-55 min,60%B→75%B;55-60 min,75%B;60-61 min,75%B→30%B;61-70 min,30%B.The flow rate was1.0 mL·min^(-1),the detection wavelength was 220 nm,and the column temperature was 30℃.Results:The minimum resolution between the main peak of Cypate and its adjacent impurity peaks was 1.80(>1.5),and that of other impurities was 1.38(>1.2).There was a good linear relationship between the concentration and the peak area in the range of 0.1-25.1μg·mL^(-1)(r=0.9990).The concentration of detection limit and quantitative limit were 0.02μg·mL^(-1)and 0.06μg·mL^(-1)respectively.In addition,the photothermal conversion effect of Cypate was obviously concentration dependent and time-dependent in 0-210 s.Conclusion:This method meets the requirements of separation between Cypate peak and impurity peaks,and is suitable for the determination of related substances of Cypate.Furthermore,the photothermal conversion effect of Cypate is good.

关 键 词：近红外荧光染料 Cypate 强降解试验 有关物质 高效液相色谱法 光热转换效应 

分 类 号：R917[医药卫生—药物分析学]