首页> 外文期刊>Journal of Pharmaceutical and Biomedical Analysis: An International Journal on All Drug-Related Topics in Pharmaceutical, Biomedical and Clinical Analysis >HPLC method for determination of SN-38 content and SN-38 entrapment efficiency in a novel liposome-based formulation, LE-SN38.
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HPLC method for determination of SN-38 content and SN-38 entrapment efficiency in a novel liposome-based formulation, LE-SN38.

机译:用于测定新型脂质体制剂LE-SN38中SN-38含量和SN-38包封效率的HPLC方法。

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摘要

A simple HPLC method was developed for quantification of SN-38, 7-ethyl-10-hydroxycamptothecin, in a novel liposome-based formulation (LE-SN38). The chromatographic separation was achieved on an Agilent Zorbax SB-C18 (4.6 mmx250 mm, 5 microm) analytical column using a mobile phase consisting of a mixture of NaH2PO4 (pH 3.1, 25 mM) and acetonitrile (50:50, v/v). SN-38 was detected at UV wavelength of 265 nm and quantitatively determined using an external calibration method. The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.05 and 0.25 microg/mL, respectively. The individual spike recovery of SN-38 ranged from 100 to 101%. The percent of relative standard deviation (%R.S.D.) of intra-day and inter-day analyses were less than 1.6%. The method validation results confirmed that the method is specific, linear, accurate, precise, robust and sensitive for its intended use. The current method was successfully applied to the determination of SN-38 content and drug entrapment efficiency in liposome-based formulation, LE-SN38 during early stage formulation development.
机译:开发了一种简单的HPLC方法,用于定量基于脂质体的新型制剂(LE-SN38)中的SN-38、7-乙基-10-羟基喜树碱。色谱分离是在Agilent Zorbax SB-C18(4.6 mmx250 mm,5微米)分析柱上进行的,流动相由NaH2PO4(pH 3.1,25 mM)和乙腈(50:50,v / v)的混合物组成。 SN-38在265 nm的紫外线波长下检测,并使用外部校准方法定量测定。检出限(LOD)和定量限(LOQ)分别为0.05和0.25 microg / mL。 SN-38的单个加标回收率在100%到101%之间。日内和日间分析的相对标准偏差(%R.S.D。)的百分比小于1.6%。方法验证结果证实,该方法对于其预期用途具有特异性,线性,准确,精确,鲁棒性和敏感性。目前的方法已成功应用于在早期脂质制剂开发过程中基于脂质体的制剂LE-SN38中SN-38含量和药物截留效率的测定。

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