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UPLC同时测定伤科跌打片中6种有效成分的含量

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目的:建立伤科跌打片中芍药苷、柚皮苷、橙皮苷、新橙皮苷、木香烃内酯、去氢木香烃内酯的UPLC测定方法。方法:色谱柱为Agilent Poroshell 120 SB-C18 100 mm ×4。6 mm,2。7μm),采用二元梯度洗脱,流动相A为乙腈,B为0。1%磷酸水溶液,柱温为30 ℃,流速1。0 mL·min-1,检测波长为230 nm。结果:芍药苷、柚皮苷、橙皮苷、新橙皮苷、木香烃内酯、去氢木香内酯6种成分在考察的进样量范围内,进样浓度与峰面积之间呈良好的线性关系(r>0。999),线性范围分别为 0。854 2~256。272 µg·mL-1(r=0。999 9)、1。057 5~317。247 µg·mL-1(r=0。999 9)、0。989 5~269。850 µg·mL-1(r=0。999 9)、1。055 6~316。689 μg·mL-1(r=0。999 9)、0。9051~271。527 μg·mL-1(r=0。999 8)、1。064 7~319。395 μg·mL-1(r=0。999 9);平均加样回收率分别为 99。4%(RSD=1。2%),104。0%(RSD=1。2%),101。6%(RSD=1。0%),102。9%(RSD=0。4%),97。0%(RSD=1。9%),104。2%(RSD=1。0%)。收集10个生产企业共74批样品,测得样品含量分别为芍药苷 0。250 8~0。653 2 mg/片,柚皮苷 0。042 2~0。930 9 mg/片,橙皮苷 0。590 9~3。978 0 mg/片、新橙皮苷0。021 2~0。592 6 mg/片、木香烃内酯0。0024~0。156 7 mg/片、去氢木香内酯 0。009 2~0。231 3 mg/片。结论:本法经方法学验证,可用于伤科跌打片的质量控制。
Simultaneous determination of six components in Shangke Dieda Tablets by UPLC
Objective:To establish a UPLC method for the simultaneous determination of paeoniflorin,naringin,hesperidin,neohesperidin,costunolide and dehydrocostuslactone to improve the quality standard of Shangke Dieda Tablets.Methods:An Agilent Poroshell 120 C18 column(100 mm × 4.6 mm;2.7 μm)was used with a mobile phase of acetonitrile and 0.1%phosphate solution with binary gradient system at a flow rate of 1.0 mL·min-1.The detection wavelength was 230 nm and the column temperature was 30 ℃.Results:Paeoniflorin,naringin,hesperidin,neohesperidin,cosinolide and dehydrocosinolide showed a good linear relationship between injection concentration and peak area(r>0.999).The linear ranges of six components were 0.854 2-256.272 μg·mL-1(r=0.999 9),1.057 5-317.247 µg·mL-1(r=0.999 9),and 0.989 5-269.850 µg·mL-1(r=0.999 9),1.055 6-316.689 μg·mL-1(r=0.999 9),0.905 1-271.527 μg·mL-1(r=0.999 8),and 1.064 7-319.395 μg·mL-1(r=0.999 9),respectively.The average recoveries of six components were 99.4%(RSD=1.2%),104.0%(RSD=1.2%),101.6%(RSD=1.0%),102.9%(RSD=0.4%),97.0%(RSD=1.9%),and 104.2%(RSD=1.0%),respectively.A total of 74 batches of samples were collected from 10 manufacturers.The contents of paeoniflorin,naringin,hesperidin,neohesperidin,coxinolactone,and dehydro-cosinolactone were 0.250 8-0.653 2,0.042 2-0.930 9,0.590 9-3.978 0,0.021 2-0.592 6,0.002 4-0.156 7,0.009 2-0.231 3 mg per tablet,respectively.Conclusion:The validated results showed that the method can be used to control the quality of Shangke Dieda Tablets.

UPLCShangke Dieda Tabletspaeoniflorinnaringinhesperidinneohesperidincostunolidedehydrocostuslactonecontent determination

田金苗、李军帅、王晓月、唐雪婷、赫爱平、周春玲

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辽宁省检验检测认证中心-辽宁省药品检验检测院,沈阳 110036

沈阳市第四人民医院,沈阳 110000

UPLC 伤科跌打片 芍药苷 柚皮苷 橙皮苷 新橙皮苷 木香烃内醋 去氢木香烃内醋 含量测定

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(4)