中国药师
中國藥師
중국약사
CHINA PHARMACIST
2014年
11期
1876-1878,1879
,共4页
高效液相色谱法%甘露六烟酯%含量测定%有关物质
高效液相色譜法%甘露六煙酯%含量測定%有關物質
고효액상색보법%감로륙연지%함량측정%유관물질
HPLC%Mannityl nicotinate%Determination%Related substances
目的：建立高效液相色谱法测定甘露六烟酯的含量及其有关物质。方法：色谱柱为Agilent Extend-C18(250 mm ×4.6 mm,5μm),以0.01 mol·L-1的醋酸铵水溶液-甲醇(40∶60)为流动相；检测波长为264 nm；柱温为30℃；流速为1.0 ml· min-1；进样量为10μl。结果：甘露六烟酯线性范围为53.6~1072.8μg·ml-1(r=1.0000),平均回收率为98.9%(RSD=0.4%,n=9)。样品中的杂质均能很好检出,各杂质与主峰之间的分离度良好,定量限为0.06μg·ml-1,检测限为0.02μg· ml-1。结论：本方法专属性强、准确、快速,适用于甘露六烟酯的质量控制。
目的：建立高效液相色譜法測定甘露六煙酯的含量及其有關物質。方法：色譜柱為Agilent Extend-C18(250 mm ×4.6 mm,5μm),以0.01 mol·L-1的醋痠銨水溶液-甲醇(40∶60)為流動相；檢測波長為264 nm；柱溫為30℃；流速為1.0 ml· min-1；進樣量為10μl。結果：甘露六煙酯線性範圍為53.6~1072.8μg·ml-1(r=1.0000),平均迴收率為98.9%(RSD=0.4%,n=9)。樣品中的雜質均能很好檢齣,各雜質與主峰之間的分離度良好,定量限為0.06μg·ml-1,檢測限為0.02μg· ml-1。結論：本方法專屬性彊、準確、快速,適用于甘露六煙酯的質量控製。
목적：건립고효액상색보법측정감로륙연지적함량급기유관물질。방법：색보주위Agilent Extend-C18(250 mm ×4.6 mm,5μm),이0.01 mol·L-1적작산안수용액-갑순(40∶60)위류동상；검측파장위264 nm；주온위30℃；류속위1.0 ml· min-1；진양량위10μl。결과：감로륙연지선성범위위53.6~1072.8μg·ml-1(r=1.0000),평균회수솔위98.9%(RSD=0.4%,n=9)。양품중적잡질균능흔호검출,각잡질여주봉지간적분리도량호,정량한위0.06μg·ml-1,검측한위0.02μg· ml-1。결론：본방법전속성강、준학、쾌속,괄용우감로륙연지적질량공제。
Objective: To establish an HPLC method for the determination of mannityl nicotinate and its related substances. Methods:The HPLC method was performed on an Agilent Extend-C18 column (250 mm × 4. 6 mm, 5 μm) with the mobile phase of 0. 01 mol·L-1 ammonium acetate solution-methanol(40∶60). The detection wavelength was 264nm. The column temperature was 30℃. The flow rate was 1. 0 ml·min-1 and the injection volume was 10 μl. Results: The linear range of mannityl nicotinate was 53. 6-1 072. 8 μg·ml-1(r=1. 000 0), and the mean recovery was 98. 9%(RSD=0. 4%,n=9). Mannityl nixotinate and its related substances could be well separated. The limit of quantitation was 0. 06 μg·ml-1 and the limit of detection was 0. 02 μg·ml-1 . Con-clusion:The method is specific, accurate and rapid. It is suitable for the quality control of mannityl nicotinate.
