基于高效液相色谱法的聚乳酸-羟基乙酸共聚物体外降解产物的测定.pdfVIP

基于高效液相色谱法的聚乳酸-羟基乙酸共聚物体外降解产物

的测定

林红赛;黄永富;黄元礼;岳卫华

【摘要】ObjectiveAnaccuratemethodnotaffectedbythematrix

interferencefordeterminationofdegradationproducts(glycolicacidand

lacticacid)ofpoly(lactic-co-glycolicacid)(PLGA)invitrodegradationwas

establishedandvalidated.Theestablishmentofthistestmethodprovides

importanttechnicalreferenceforqualitycontrolofdegradationproducts

ofPLGAproduct.MethodsChromatographicconditionsandsample

pretreatmentmethodwereconfirmedbyoptimizationofchromatographic

column,chromatographicconditionsandcomparisonofchromatographic

peakareaoflacticacidandglycolicacidstandardsolutionswithdifferent

pHvalue.HPLCanalysisofdegradationproductswereperformedbya

Waters1525chromatographyequippedwithanultravioletdetectorand

quantifiedbyexternalstandardmethod.Thedetectionwavelengthwasat

210nm.ResultsAgoodseparationwasobtainedbetweenglycolicacidand

lacticacidintheconditionofhydrophilicC18column,20mmol/LKH2PO4

solution(pH=2.8)asthemobilephasewithaflowrateof0.6mL/min.In

addition,foraccuratequantification,thepHvalueofsampledegradation

productsshouldbeadjustedto2.8to3.5.Thelinearrangeofglycolicacid

was2.500μg/mLto250.0μg/mL(r=0.9999)withlimitofquantitationof

O.48μg/mL.Thelinearrangeoflacticacidwas2.642μg/mLto264.2

μg/mL(r=0.9999)withlimitofquantitationof1.0μg/mL.Therecoveriesof

glycolicacidandlacticacidwere99.4％to102.6％,and97.9％to

103.2％,respectively.ConclusionsThemethodissimple,accurate,lowtest

costandnotaffectedbypHvalueofphosphatebufferedsaline

interference,whichwassuitableforthecontentdeterminationofinvitro

degradationproductsofPLGAproduct.%目的建立准确、不受基质干扰的测

定聚乳酸-羟基乙酸共聚物[poly(lactic-co-glycolicacid),PLGA]降解液中降解产物

乙醇酸和乳酸的分析方法并进行方法验证,为PLGA类产品的降解液的质量分析提

供重要的技术参考.方法通过优化色谱柱、色谱条件和不同pH值的乳酸和