中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2015年
16期
87-88,89
,共3页
反相高效液相色谱法%川楝素%含量测定
反相高效液相色譜法%川楝素%含量測定
반상고효액상색보법%천련소%함량측정
RP-HPLC%toosendanin%content determination
目的:建立测定川楝子药材中川楝素含量的反相高效液相色谱(RP-HPLC)法,并与高效液相色谱-质谱(HPLC-MS)法进行比较。方法色谱柱为Agilent TC-C18柱(250 mm ×4.6 mm,5μm),流动相为乙腈-水(25:75),检测波长为210 nm,柱温为35℃,流速为1 mL/min,进样量为10μL。结果川楝素质量浓度在0.036~0.280 g/L范围内与峰面积线性关系良好( r=0.9998),平均回收率为102.38%,RSD=3.89%( n=6)。应用RP-HPLC和HPLC-MS法检测3批次药材川楝素含量分别为0.17%,0.17%,0.18%和0.18%,0.18%,0.19%。结论所建立方法使用仪器普及率高,操作简单,成本低,检测精密度和准确度满足应用要求。与HPLC-MS法比较,RP-HPLC法检测含量稍高,基层药品检验部门和一般制药企业可利用该方法对川楝素进行质量控制。
目的:建立測定川楝子藥材中川楝素含量的反相高效液相色譜(RP-HPLC)法,併與高效液相色譜-質譜(HPLC-MS)法進行比較。方法色譜柱為Agilent TC-C18柱(250 mm ×4.6 mm,5μm),流動相為乙腈-水(25:75),檢測波長為210 nm,柱溫為35℃,流速為1 mL/min,進樣量為10μL。結果川楝素質量濃度在0.036~0.280 g/L範圍內與峰麵積線性關繫良好( r=0.9998),平均迴收率為102.38%,RSD=3.89%( n=6)。應用RP-HPLC和HPLC-MS法檢測3批次藥材川楝素含量分彆為0.17%,0.17%,0.18%和0.18%,0.18%,0.19%。結論所建立方法使用儀器普及率高,操作簡單,成本低,檢測精密度和準確度滿足應用要求。與HPLC-MS法比較,RP-HPLC法檢測含量稍高,基層藥品檢驗部門和一般製藥企業可利用該方法對川楝素進行質量控製。
목적:건립측정천련자약재중천련소함량적반상고효액상색보(RP-HPLC)법,병여고효액상색보-질보(HPLC-MS)법진행비교。방법색보주위Agilent TC-C18주(250 mm ×4.6 mm,5μm),류동상위을정-수(25:75),검측파장위210 nm,주온위35℃,류속위1 mL/min,진양량위10μL。결과천련소질량농도재0.036~0.280 g/L범위내여봉면적선성관계량호( r=0.9998),평균회수솔위102.38%,RSD=3.89%( n=6)。응용RP-HPLC화HPLC-MS법검측3비차약재천련소함량분별위0.17%,0.17%,0.18%화0.18%,0.18%,0.19%。결론소건립방법사용의기보급솔고,조작간단,성본저,검측정밀도화준학도만족응용요구。여HPLC-MS법비교,RP-HPLC법검측함량초고,기층약품검험부문화일반제약기업가이용해방법대천련소진행질량공제。
Objective To establisb a RP-HPLC metbod for tbe determination of tbe toosendanin content in Melia toosendan and to compare it witb tbe HPLC-MS. Methods Tbe cbromatograpbic conditions were as follows:tbe Agilent TC-C18 column(250 mm × 4. 6 mm,5 μm),tbe mobile pbase of acetonitrile-water(25 :75)at a flow rate of 1 mL/min,tbe detection wavelengtb of 210 nm and tbe sample size of 10 μL. Results Tbe linear range of toosendanin in Melia toosendan was 0. 036-0. 280 g/L( r=0. 999 8). Tbe av-erage recovery rate was 102. 38%,RSD=3. 89% ( n=6 ) . Tbe toosendanin contents in 3 batcbes of medicinal material determined by RP- HPLC and HPLC-MS were 0. 17%,0. 17%,0. 18% and 0. 18%,0. 18%,0. 19% respectively. Conclusion Tbe establisbed metbod bas bigb popularizing rate for using instrument,is easy to operate,bas low cost,its detection precision and accuracy meet tbe application requirements. Compared witb HPLC-MS,tbe detected content of RP-HPLC is sligbtly bigber. Tbe primary drug inspection department and general pbarmaceutical enterprise can use tbis metbod to conduct tbe quality control on toosendanin.