超高效液相色谱法测定注射用甲泼尼龙琥珀酸钠含量的不确定度评定
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摘要
目的建立超高效液相色谱(UPLC)法测定注射用甲泼尼龙琥珀酸钠含量的不确定度评价方法。方法采用UPLC测定注射用甲泼尼龙琥珀酸钠含量,根据检验过程,分析影响不确定度因素的来源,对各个不确定度因素进行评定,得出扩展不确定度,对含量测定结果进行风险评估。结果本试验合成标准不确定度为0.36%,扩展不确定度为0.7%,含量测定结果报告为(100.2±0.7)%,k=2。结论该方法适用于UPLC内标法测定注射用甲泼尼龙琥珀酸钠含量的不确定度。
OBJECTIVE To evaluate the measurement uncertainty for the assay determination of methylprednisolone sodium succinate for injection by UPLC. METHODS UPLC was established to determinate the content of methylprednisolone sodium succinate for injection. According to the inspection process,the variable parameters affect uncertainty were analyzed,the combined uncertainty and extended uncertainty were obtained. RESULTS The combined uncertainty was 0. 36%,the expanded measurement uncertainty was 0.7%,and the assay of methylprednisolone sodium succinate for injection was( 100.2±0.7) %,k = 2. CONCLUSION The method is suitable for the uncertainty measurement evaluation of the content determination of methylprednisolone sodium succinate for injection.
OBJECTIVE To evaluate the measurement uncertainty for the assay determination of methylprednisolone sodium succinate for injection by UPLC. METHODS UPLC was established to determinate the content of methylprednisolone sodium succinate for injection. According to the inspection process,the variable parameters affect uncertainty were analyzed,the combined uncertainty and extended uncertainty were obtained. RESULTS The combined uncertainty was 0. 36%,the expanded measurement uncertainty was 0.7%,and the assay of methylprednisolone sodium succinate for injection was( 100.2±0.7) %,k = 2. CONCLUSION The method is suitable for the uncertainty measurement evaluation of the content determination of methylprednisolone sodium succinate for injection.
引文
[1]国家质量监督检验检疫总局.测量不确定度评定与表示[S].JJF1059.1-2012.北京:中国计量出版社,2012.
[2]Liu S Y,Hu C Q. A comparative uncertainty study of the calibration of macrolide antibiotic reference standards using quantitative nuclear magnetic resonance and mass balance methods[J]. Anal Chim Acta,2007,60(2):114.
[3]栗建明,杨洁瑜,侯慧婵,等.丹参川芎嗪注射液中丹参素钠和原儿茶醛的含量测定及不确定度评定[J].中药新药与临床药理,2015,26(4):546-549.
[4]刘肃,苏广海.磷酸奥司他韦颗粒含量测定的不确定度评定[J].中国药物评价,2016,33(3):129-132.
[5]杜碧莹.离子色谱法测定氯膦酸二钠注射液含量的测量不确定度评定[J].今日药学,2017,27(3):171-173.
[6]王江华,徐静,汤智慧.注射用甲泼尼龙琥珀酸钠致低钾周期性麻痹1例[J].中国药物应用与监测,2017,14(5):317-318.
[7]全国流量容量计量技术委员会.常用玻璃检定规程[S].JJG196-2006.北京:中国计量出版社,2006.
[2]Liu S Y,Hu C Q. A comparative uncertainty study of the calibration of macrolide antibiotic reference standards using quantitative nuclear magnetic resonance and mass balance methods[J]. Anal Chim Acta,2007,60(2):114.
[3]栗建明,杨洁瑜,侯慧婵,等.丹参川芎嗪注射液中丹参素钠和原儿茶醛的含量测定及不确定度评定[J].中药新药与临床药理,2015,26(4):546-549.
[4]刘肃,苏广海.磷酸奥司他韦颗粒含量测定的不确定度评定[J].中国药物评价,2016,33(3):129-132.
[5]杜碧莹.离子色谱法测定氯膦酸二钠注射液含量的测量不确定度评定[J].今日药学,2017,27(3):171-173.
[6]王江华,徐静,汤智慧.注射用甲泼尼龙琥珀酸钠致低钾周期性麻痹1例[J].中国药物应用与监测,2017,14(5):317-318.
[7]全国流量容量计量技术委员会.常用玻璃检定规程[S].JJG196-2006.北京:中国计量出版社,2006.