HPLC法测定硝呋太尔制霉菌素软胶囊中制霉菌素含量的方法研究.docxVIP

HPLC法测定硝呋太尔制霉菌素软胶囊中

制霉菌素含量的方法研究

【摘要】目的：建立测定硝呋太尔制霉菌素阴道软胶囊中制霉菌素含量的HPLC法。方法：采用振荡加低温超声的方式对硝呋太尔制霉菌素阴道软胶囊内容物进行提取。采用HPLC法测定其中制霉菌素的含量。色谱条件：色谱柱为ECOSILC18(4.6*250mm，5μm)，流动相A溶液为0.38%乙酸铵溶液-乙腈（71：29），流动相B溶液为0.38%乙酸铵溶液-乙腈（40：60），线性梯度洗脱；流速1.5mL/min；柱温控制为35℃；检测器为紫外检测器，检测波长为305nm，进样量为10μL，运行时间约70min。结果：硝呋太尔制霉菌素阴道软胶囊中制霉菌素含量测定方法的专属性好，辅料空白对主成分无干扰影响；重复性较好；中间精密度较好；制霉菌素浓度在0.04mg/mL~1.0mg/mL范围内线性关系良好；另外，回收率93.02%~97.49%，相对标准偏差1.74%，均符合要求。结论：硝呋太尔制霉菌素阴道软胶囊中制霉菌素含量测定的高效液相色谱法，方法可行，可为硝呋太尔制霉菌素阴道软胶囊的质量控制提供更方便准确的检测方法。

【关键词】硝呋太尔制霉菌素阴道软胶囊；制霉菌素；高效液相色谱法；含量测定

StudyonthemethodofdeterminationofnystatincontentinnifurtelnystatinsoftcapsulesbyHPLCmethod

[Abstract]Objective:ToestablishanHPLCmethodforthedeterminationofnystatincontentinnifurterolnystatinvaginalsoftgels.Methods:Thecontentsofnifurterylnystatinvaginalsoftgelswereextractedbyshakingandcryoultrasound.ThecontentofnystatinwasdeterminedbyHPLCmethod.Chromatographicconditions:thecolumnwasECOSILC18(4.6*250mm,5μm),mobilephaseAsolutionwas0.38%ammoniumacetatesolution-acetonitrile(71:29),mobilephaseBsolutionwas0.38%ammoniumacetatesolution-acetonitrile(40:60),lineargradientelution;Flowrate1.5mL/min;Thecolumntemperatureiscontrolledto35℃;Thedetectorisanultravioletdetectorwithadetectionwavelengthof305nm,aninjectionvolumeof10μL,andarunningtimeofabout70minutes.Results:Thedeterminationmethodofnystatincontentinnifurtelnystatinvaginalsoftgelshasgoodspecificity,andtheblankofauxiliarymaterialshasnointerferenceeffectonthemaincomponents;Goodrepeatability;Theintermediateprecisionisbetter;Theconcentrationofnystatinhadagoodlinearrelationshipintherangeof0.04mg/mL~1.0mg/mL.Therecoveryrateofthismethodwas93.02%~97.49%,andtherelativestandarddeviationwas1.74%,allofwhichmettherequirements.Conclusion:Thehighperformanceliquidchromatographymethodforthedetermination