1、Re、Rb1含量的方法。方法 采用Waters Xselect® HSS C18（3.0×150 mm，2.5 μm）色譜柱，以0.05%磷酸溶液-乙腈為流動(dòng)相梯度洗脫，進(jìn)樣量為5 μL，檢測(cè)波長(zhǎng)為203 nm，柱溫28℃。進(jìn)行線性關(guān)系考察，重復(fù)性、中間精密度、準(zhǔn)確性、耐用性試驗(yàn)。取10批YQFM，按照本研究建立的方法和YQFM國家藥品標(biāo)準(zhǔn)（YBZ07062006-2009Z-2015）中的HPLC含量測(cè)定法[5]進(jìn)行測(cè)定。結(jié)果 人參皂苷Rg1、人參皂苷Re、人參皂苷Rb1分別在0.019 37~0.387 40、0.020 32~0.406 40、0.050 00~0.999 9 mg/mL線性關(guān)系良好（R>0.999 9），重復(fù)性、中間精密度、準(zhǔn)確性、耐用性等均滿足定量分析要求。含量測(cè)定結(jié)果與國家標(biāo)準(zhǔn)方法比較無明顯差異。結(jié)論 研究建立的方法可用于人參皂苷Rg1、Re、Rb1含量的測(cè)定，與傳統(tǒng)的HPLC-UV法相比，本方法具有分析速度快、節(jié)約溶劑等特點(diǎn)，同時(shí)相較于UPLC-MS/MS法，具有經(jīng)濟(jì)、簡(jiǎn)便的優(yōu)勢(shì)。;Objective To establish a UHPLC-UV method for the analysis of ginsenoside Rg1, Re, and Rb1 in Yiqi Fumai Lyophilized Injection. Methods The determination was achieved on a Waters Xselect® HSS C18 column (3.0 mm×150 mm, 2.5 μm) with a gradient elution system of 0.05% phosphoric acid solution-acetonitrile. The injection volume was 5 μL with detection wavelength of 203 nm, column temperature was maintained at 28℃. Linear relationship, repeatability, intermediate precision, accuracy and durability were tested. Ten batches of YQFM were selected and determined according to the method established in this study and the HPLC content determination method in YQFM national drug standard (YBZ07062006-2009Z-2015). Results Ginsenoside Rg1, ginsenoside Re, Ginsenoside Rb1 the linear relationship was good in the range of 0.019 37-0.387 40, 0.020 32-0.406 40, 0.050 00-0.999 90 mg/mL respectively (r > 0.999 9). Repeatability, intermediate precision, accuracy and durability meet the requirements of quantitative analysis. There was no significant difference between the content determination results and the national standard method. Conclusion The method can be used for the determination of Ginsenoside Rg1, Re and Rb1. Compared with HPLC-UV method, this method has the characteristics of fast analysis speed and solvent saving. At the same time, it has the advantages of economy and simplicity compared with UPLC-MS/MS method."/>

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首頁 > 過刊瀏覽>2020年第43卷第8期 >2020,43(8):1587-1591. DOI:10.7501/j.issn.1674-6376.2020.08.020
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UPLC-UV法測(cè)定注射用益氣復(fù)脈（凍干）中人參皂苷Rg1、Re、Rb1

UPLC-UV method for analysis of Ginsenoside Rg1, Re, and Rb1 in Yiqi Fumai Lyophilized Injection

發(fā)布日期：2020-08-05
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    [關(guān)鍵詞]
    [摘要]
    目的 建立UHPLC-UV測(cè)定注射用益氣復(fù)脈（凍干）（YQFM）中人參皂苷Rg1、Re、Rb1含量的方法。方法 采用Waters Xselect® HSS C18（3.0×150 mm，2.5 μm）色譜柱，以0.05%磷酸溶液-乙腈為流動(dòng)相梯度洗脫，進(jìn)樣量為5 μL，檢測(cè)波長(zhǎng)為203 nm，柱溫28℃。進(jìn)行線性關(guān)系考察，重復(fù)性、中間精密度、準(zhǔn)確性、耐用性試驗(yàn)。取10批YQFM，按照本研究建立的方法和YQFM國家藥品標(biāo)準(zhǔn)（YBZ07062006-2009Z-2015）中的HPLC含量測(cè)定法[5]進(jìn)行測(cè)定。結(jié)果 人參皂苷Rg1、人參皂苷Re、人參皂苷Rb1分別在0.019 37~0.387 40、0.020 32~0.406 40、0.050 00~0.999 9 mg/mL線性關(guān)系良好（R>0.999 9），重復(fù)性、中間精密度、準(zhǔn)確性、耐用性等均滿足定量分析要求。含量測(cè)定結(jié)果與國家標(biāo)準(zhǔn)方法比較無明顯差異。結(jié)論 研究建立的方法可用于人參皂苷Rg1、Re、Rb1含量的測(cè)定，與傳統(tǒng)的HPLC-UV法相比，本方法具有分析速度快、節(jié)約溶劑等特點(diǎn)，同時(shí)相較于UPLC-MS/MS法，具有經(jīng)濟(jì)、簡(jiǎn)便的優(yōu)勢(shì)。
    [Key word]
    [Abstract]
    Objective To establish a UHPLC-UV method for the analysis of ginsenoside Rg1, Re, and Rb1 in Yiqi Fumai Lyophilized Injection. Methods The determination was achieved on a Waters Xselect® HSS C18 column (3.0 mm×150 mm, 2.5 μm) with a gradient elution system of 0.05% phosphoric acid solution-acetonitrile. The injection volume was 5 μL with detection wavelength of 203 nm, column temperature was maintained at 28℃. Linear relationship, repeatability, intermediate precision, accuracy and durability were tested. Ten batches of YQFM were selected and determined according to the method established in this study and the HPLC content determination method in YQFM national drug standard (YBZ07062006-2009Z-2015). Results Ginsenoside Rg1, ginsenoside Re, Ginsenoside Rb1 the linear relationship was good in the range of 0.019 37-0.387 40, 0.020 32-0.406 40, 0.050 00-0.999 90 mg/mL respectively (r > 0.999 9). Repeatability, intermediate precision, accuracy and durability meet the requirements of quantitative analysis. There was no significant difference between the content determination results and the national standard method. Conclusion The method can be used for the determination of Ginsenoside Rg1, Re and Rb1. Compared with HPLC-UV method, this method has the characteristics of fast analysis speed and solvent saving. At the same time, it has the advantages of economy and simplicity compared with UPLC-MS/MS method.
    [中圖分類號(hào)]
    R285.6
    [基金項(xiàng)目]
    天津市科技計(jì)劃項(xiàng)目（18YFCZZC00430）
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