首页|电感耦合等离子体发射光谱法测定富马酸奥赛利定注射液中24种元素含量及其胶塞迁移量

电感耦合等离子体发射光谱法测定富马酸奥赛利定注射液中24种元素含量及其胶塞迁移量

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目的 建立测定富马酸奥赛利定注射液中24种元素含量及其胶塞迁移量的电感耦合等离子体发射光谱(ICP-OES)法。方法 泵速为50 r/min，辅助气流量为0。5 L/min，射频功率为1 150 W，检测波长分别为394。4 nm(铝)、189。0 nm(砷)、249。7 nm(硼)、233。5 nm(钡)、393。3 nm(钙)、214。4 nm(镉)、404。0 nm(铈)、228。6 nm(钴)、267。7 nm(铬)、224。7 nm(铜)、238。2 nm(铁)、184。9 nm(汞)、670。7 nm(锂)、279。5 nm(镁)、259。3 nm(锰)、202。0 nm(钼)、231。6 nm(镍)、220。3 nm(铅)、206。8 nm(锑)、212。4 nm(硅)、323。4 nm(钛)、292。4 nm(钒)、224。8 nm(钨)、213。8 nm(锌)。进行模拟试验，测定富马酸奥赛利定注射液所用胶塞在药品、酸性、碱性、乙醇溶液中的迁移量。结果 24种元素的质量浓度在0～1 000 ng/mL范围内与峰面积响应值线性关系良好(r＞0。995，n=8);方法检测限为0。002～0。68 μg/支，方法定量限为0。01～2。28 μg/支;精密度试验结果的RSD为0。20％～1。36％(n=6);稳定性试验结果的变化率为0。10％～10。56％;平均回收率为92。44％～103。32％，RSD为0。24％～2。93％(n=6)。样品中仅检出硼、钙、镁、硅、锌，含量分别为1。20，0。81，0。08，0。70，0。09 μg，其余元素均未检出。胶塞迁移量最多的元素为钙、镁、锌，最大迁移量分别为每支2。16，7。75，26。25 μg，均低于其分析评价阈值。结论 ICP-OES法可快速、准确地测定富马酸奥赛利定注射液中24种元素的含量。迁移的钙、镁、锌不影响药品的安全性，但应重点关注胶塞中锌元素的迁移。
Content Determination of 24 Elements in Oliceridine Fumarate Injection and Rubber Stopper Migration by ICP-OES
Objective To establish an inductively coupled plasma-optical emission spectroscopy(ICP-OES)method for the content determination of 24 elements in Oliceridine Fumarate Injection and rubber stopper migration.Methods The pump speed was 50 r/min,the flow rate of auxiliary air was 0.5 L/min,the RF power was 1 150 W,and the detection wavelengths were 394.4 nm(aluminum),189.0 nm(arsenic),249.7 nm(boron),233.5 nm(barium),393.3 nm(calcium),214.4 nm(cadmium),404.0 nm(cerium),228.6 nm(cobalt),267.7 nm(chromium),224.7 nm(copper),238.2 nm(iron),184.9 nm(mercury),670.7 nm(lithium),279.5 nm(magnesium),259.3 nm(manganese),202.0 nm(molybdenum),231.6 nm(nickel),220.3 nm(lead),206.8 nm(antimony),212.4 nm(silicon),323.4 nm(titanium),292.4 nm(vanadium),224.8 nm(tungsten),and 213.8 nm(zinc),respectively.The simulation experiment was conducted to determine the migration of 24 elements in the rubber stopper for Oliceridine Fumarate Injection in drug,acidic,alkaline,and ethanol solutions.Results The linear ranges of 24 elements were 0-1 000 ng/mL(r＞0.995,n=8),the limit of detection of the method was in the range of 0.002-0.68 μg/vial,the limit of quantification of the method was in the range of 0.01-2.28 μg/vial.The RSD of the precision test result was in the range of 0.20％-1.36％(n=6).The change rate of stability test result was in the range of 0.10％-10.56％.The average recoveries of of 24 elements were in the range of 92.44％-103.32％,with the RSDs of 0.24％-2.93％(n=6).Only boron,calcium,magnesium,silicon,and zinc were detected in samples,with contents of 1.20,0.81,0.08,0.70,and 0.09 μg,respectively,and no other elements were detected.The elements with the highest migration in the rubber stopper were calcium,magnesium,and zinc,with maximum migration of 2.16,7.75,and 26.25 μg/vial,respectively,all of which were lower than the analytical evaluation threshold(AET).Conclusion ICP-OES can quickly and accurately determine the content of 24 elements in Oliceridine Fumarate Injection.The migration of calcium,magnesium,and zinc does not affect the safety of the drug,but special attention should be paid to the migration of zinc elements in the rubber stopper.

Oliceridine Fumarate InjectionICP-OESmetals and harmful elementsmigrationrubber stopper

陈菲、任学毅、胡幸、陈竹、詹宇杰、王琳、武静文

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重庆市食品药品检验检测研究院·国家药品监督管理局麻醉精神药品质量监测重点实验室,重庆 401121

西南大学药学院,重庆 400716

西南医科大学药学院,四川 泸州 646000

富马酸奥赛利定注射液 电感耦合等离子体发射光谱法 金属及有害元素 迁移量 胶塞

国家药品监督管理局麻醉精神药品质量监测重点实验室开放课题项目重庆市科学技术局科研机构绩效激励引导专项项目

NPKF-2021-03cstc2022jxjl120003

2024

10.3969/j.issn.1006-4931.2024.17.005

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子：1.369
ISSN：1006-4931
年,卷(期)：2024.33(17)