广州化工
廣州化工
엄주화공
GUANGZHOU CHEMICAL INDUSTRY AND TECHNOLOGY
2014年
14期
140-142
,共3页
硫酸异帕米星%高效液相色谱-共振光散射检测法%含量测定
硫痠異帕米星%高效液相色譜-共振光散射檢測法%含量測定
류산이파미성%고효액상색보-공진광산사검측법%함량측정
isepamicin sulfate%HPLC-RLS%content determination
用高效液相色谱-共振光散射检测法测定了注射用硫酸异帕米星的含量。采用Agilent ZORBAX SB-C18（4.6 mm ×250 mm，5μm）为色谱柱，流动相为水砄乙腈＝97：3（φ），流速0.5 mL/min，荧光检测器λex ＝λem ＝488 nm，探针达旦黄为20μg/mL的BR溶液，单泵流速0.20 mL/min。结果表明：异帕米星在5～30μg/mL浓度范围内有良好的线性关系，检测限为1.0μg/mL；高、中、低三种浓度的回收率均大于98％。本方法操作简便，方法的精密度、准确性均能满足制剂质量控制的要求，为硫酸异帕米星含量测定提供了一种新的方法。
用高效液相色譜-共振光散射檢測法測定瞭註射用硫痠異帕米星的含量。採用Agilent ZORBAX SB-C18（4.6 mm ×250 mm，5μm）為色譜柱，流動相為水砄乙腈＝97：3（φ），流速0.5 mL/min，熒光檢測器λex ＝λem ＝488 nm，探針達旦黃為20μg/mL的BR溶液，單泵流速0.20 mL/min。結果錶明：異帕米星在5～30μg/mL濃度範圍內有良好的線性關繫，檢測限為1.0μg/mL；高、中、低三種濃度的迴收率均大于98％。本方法操作簡便，方法的精密度、準確性均能滿足製劑質量控製的要求，為硫痠異帕米星含量測定提供瞭一種新的方法。
용고효액상색보-공진광산사검측법측정료주사용류산이파미성적함량。채용Agilent ZORBAX SB-C18（4.6 mm ×250 mm，5μm）위색보주，류동상위수결을정＝97：3（φ），류속0.5 mL/min，형광검측기λex ＝λem ＝488 nm，탐침체단황위20μg/mL적BR용액，단빙류속0.20 mL/min。결과표명：이파미성재5～30μg/mL농도범위내유량호적선성관계，검측한위1.0μg/mL；고、중、저삼충농도적회수솔균대우98％。본방법조작간편，방법적정밀도、준학성균능만족제제질량공제적요구，위류산이파미성함량측정제공료일충신적방법。
High performance liquid chromatography ( HPLC) coupled with resonance light scattering ( RLS) method were established for determination of the isepamicin sulfate in the injection.The chromatographic separation was performed on a Agilent ZORBAX SB C18 (4.6 mm ×250 mm, 5 μm) column.The mobile phase was consisted of water:acetonitrile=97:3(φ) at flow rate of 0.5 mL/min, the fluorescence detertor was set at λex =λem =488 nm, Titan Yellow of 20 μg/mL with the BR solution was chosen as molecular recognition probe , and the flow rate of probe solution was 0.20 mL/min at post-column.The concentration of isepamicin in the linear range of 5.0 ~30.0 μg/mL had a good linear relationship , the detection limit was 1.0 μg/mL, low, and medium and high three kinds of recoveries are greater than 98%.The method was simple , more accurate and sensitivity , and provided an effective way in quality control of isepamicin sulfate injection.
