HPLC法同时测定醋酸亮丙瑞林缓释微球中的乙醇酸和乳酸  

Determination of Glycolic Acid and Lactic Acid in Leuprorelin Acetate Sustained-release Microspheres by HPLC

作　　者：宋盛发 夏昀卿 刘万卉[1,2] 许丽晓 马永超 SONG Shengfa;XIA Yunqing;LIU Wanhui;XU Lixiao;MA Yongchao(Key Lab.of Molecular Pharmacology and Drug Evaluation,Ministry of Education,Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong,School of Pharmacy,Yantai University,Yantai 264005;National Key Lab.of Advanced Drug Delivery and Release Systems,Luye Pharma Group Ltd.,Yantai 264003)

机构地区：[1]烟台大学药学院,新型制剂与生物技术药物研究山东省高校协同创新中心,分子药理和药物评价教育部重点实验室(烟台大学),山东烟台264005 [2]绿叶制药集团有限公司先进药物递释系统全国重点实验室,山东烟台264003

出　　处：《中国医药工业杂志》2024年第7期1003-1007,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了HPLC法同时测定醋酸亮丙瑞林缓释微球中乙醇酸和乳酸的含量。色谱柱采用Waters XSelect HSS T3柱(4.6 mm×100 mm,3.5μm),流动相A为磷酸和水的混合溶液,B为乙腈,梯度洗脱。检测波长为210 nm,流速为1.0 mL/min,柱温为40℃,进样量为5μL。结果显示,该方法专属性良好,乙醇酸和乳酸在0.015~0.06 mg/mL内线性关系良好。乙醇酸和乳酸的检测限均为0.008 mg/mL,定量限均为0.03 mg/mL。乙醇酸和乳酸的平均回收率分别为99.2%、101.6%,RSD分别为1.54%、1.37%。该法可用于醋酸亮丙瑞林缓释微球及其降解过程中乙醇酸和乳酸含量的测定。An HPLC method was established to simultaneously determine the contents of glycolic acid and lactic acid in leuprorelin acetate sustained-release microspheres.The Waters XSelect HSS T3 column(4.6 mm×100 mm,3.5μm)was used,and the analysis was carried out in the gradient elution mode with the mixed solution of phosphoric acid and water as mobile phase A,and acetonitrile as mobile phase B.The detection wavelength was 210 nm,the flow rate was 1.0 mL/min,the column temperature was 40℃,and the injection amount was 5μL.The results showed that the method had good specificity,and it was linear for glycolic acid and lactic acid in the ranges of 0.015-0.06 mg/mL.The detection limits for both glycolic acid and lactic acid were 0.008 mg/mL,and the quantification limits were 0.03 mg/mL.The average recovery rates of glycolic acid and lactic acid were 99.2%and 101.6%,respectively,with the RSDs were 1.54%and 1.37%,respectively.The results indicated that this method could be used for the determination of glycolic acid and lactic acid content in leuprorelin acetate sustained-release microspheres and their degradation process.

关 键 词：醋酸亮丙瑞林缓释微球 HPLC PLGA 乙醇酸 乳酸 

分 类 号：R917[医药卫生—药物分析学]