HPLC-UV-ELSD法同时测定复方妥布霉素滴眼液中妥布霉素和地塞米松的含量
HPLC-UV-ELSD simultaneous determination of tobramycin and dexamethasone in the compound tobramycin eye drops
分类号:
出版年·卷·期(页码):2014,34 (2):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------
目的:建立高效液相色谱-紫外检测器-蒸发光散射检测器联用法(HPLC-UV-ELSD)同时测定复方妥布霉素滴眼液中妥布霉素和地塞米松的含量。方法:采用Capcell pak MG C18(4.6 mm×150 mm,5 μm)色谱柱,流动相为0.2 mol·L-1三氟乙酸水溶液-乙腈(90:10),流速1.0 mL·min-1;检测波长240 nm;进样量:20 μL;ELSD检测器:漂移管温度为90 ℃,载气1.8 Bar。结果:妥布霉素、地塞米松分别在27.65~276.54 mg·L-1、10.01~100.06 mg·L-1范围内呈良好的线性关系,r分别为0.9993、0.9997;平均回收率(n=6)分别为99.2%(RSD=0.65%)、99.6%(RSD=0.58%)。结论:该方法简便,重复性好,可用于同时测定复方妥布霉素滴眼液中妥布霉素和地塞米松的含量。
-----英文摘要:---------------------------------------------------------------------------------------
Objective: To establish a quantitative method for the determination of tobramycin and dexamethasone in the compound tobramycin eye drops by high-performance liquid chromatography coupled with ultraviolet and evaporative light-scattering detectors (HPLC-UV-ELSD). Methods: A Capcell pak MG C18 column (4.6 mm×150 mm,5 μm) was adopted.The mobile phase consisted of a mixture of 0.2 mol·L-1 trifluoroacetic acid aqueous solution-acetonitrile (90:10) at a flow rate of 1.0 mL·min-1,the detection wavelength was set at 240 nm.The drift tube temperature was 90 ℃,ELSD was used as the detector with pressure of nebulizing gas of 1.8 Bar. Results: The calibration curve showed a good linearity in the ranges of 27.65-276.54 mg·L-1 (r=0.9993) for tobramycin,10.01-100.06 mg·L-1 (r=0.9997) for dexamethasone,respectively.The average recoveries (n=6) of tobramycin and dexamethasone were 99.2%(RSD=0.65%),99.6% (RSD=0.58%),respectively. Conclusions: The developed method is simple and reproducible,which can be used for quantitative determination of tobramycin and dexamethasone in the compound tobramycin eye drops.
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[1] ChP 2010.Vol Ⅱ(中国药典2010年版.二部)[S].2010:364
[2] ChP 2010.Vol Ⅱ(中国药典2010年版.二部)[S].2010:249
[3] YAN Ru-qing(严汝庆), HUANG Bei-xiong(黄北雄).The determination of the contents of tobramycin eye drops by HPLC(高效液相色谱法测定妥布霉素滴眼液含量)[J].Chin Hosp Pharm J(中国医院药学杂志), 2008, 28(20):1808
[4] WU Wen-yao(吴文耀), WANG Ling(汪玲).Determination of tobramycin contents in eye drops by RP-HPLC(反相高效液相色谱法测定妥布霉素滴眼液含量)[J].Her Med(医药导报), 2007, 26(3):291
[5] HE Dan(何丹), YANG Lin(杨林).Determination of tobramycin sulfate drops by HPLC with post-column derivation(柱后衍生化高效液相色谱法测定妥布霉素滴眼液含量)[J].Chin J Antibiot(中国抗生素杂志), 2010, 35(10):771
[6] YANG Li(杨莉), PAN Guo-hong(潘国洪), YI Wei(易薇), et al.Content determination for compound tobramycin eye drops (复方妥布霉素滴眼液的含量测定)[J].Hubei Coll Tradit Chin Med(湖北中医学院学报), 2010, 12(3):44
[7] YAN Yan(颜彦).WANG Kang-jun(王康俊).Determination of tobramycin sulfate injection drops by HPLC-ELSD method(HPLC-ELSD测定硫酸妥布霉素注射液的含量[J]).Chin Trop Med(中国热带医学), 2007, 7(9):1674
[8] LIN Ming-shi(林明世), XIAO Guang-xia(肖广霞).Determination of tobramycin in tobramycin dexamethasone eye drops by HPLC-ELSD(HPLC-ELSD法测定妥布霉素地塞米松滴眼液中妥布霉素的含量)[J].China Pharm(中国药房), 2008, 19(25):1977
[9] LIU Yong-mei(刘咏梅).Determination of tobramycin eye drops by HPLC-ELSD (HPLC-ELSD测定妥布霉素滴眼液的含量)[J].Chin J Mod App Pharm(中国现代应用药学杂志), 2009, 25(7):590
[10] ZHENG Yan(郑妍), GAO Lin(高琳).Determination of tobramycin content in eye drops by HPLC-ELSD(HPLC-ELSD测定妥布霉素滴眼液的含量)[J].Northwest Pharm J(西北药学杂志), 2011, 26(4):259
[11] YBH00112008, State Food and Drug Administration Standard(国家食品药品监督管理局标准)[S].2008
[12] CHEN Ning-lin(陈宁林), ZHANG Hua-yan(张华艳).Determination of tobramycin by HPLC-ELSD method(高效液相色谱-蒸发光散射检测妥布霉素的含量)[J].Chin Hosp Pharm J(中国医院药学杂志), 2007, 27(9):1248
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