摘要
目的建立测定不同材质、同种材质不同品种药品包装材料(简称药包材)溶出物中总有机碳(TOC)含量的紫外/过硫酸盐湿法氧化非色散红外检测(NDIR)法。方法收集金属、塑料、橡胶、复合材料4类材质的85批样品,选择过硫酸钠(质量浓度为80 g/L)作为氧化剂,以邻苯二甲酸氢钾(KHP)和蔗糖为标准物质,采用TOC分析仪测定TOC响应值,参考2020年版《中国药典(四部)》0862制药用水中TOC测定法进行方法学考察。结果KHP和蔗糖2种标准物质的质量浓度分别在0.20~20.00 mg/L和0.25~50.00 mg/L范围内与仪器响应值线性关系良好(r≥0.9999);仪器检测限为33.11~34.30μg/L,定量限为100.34~103.93μg/L;精密度试验的RSD为0.16%~7.46%(n=6);KHP、蔗糖的加样回收率分别为91.37%~119.78%和86.08%~121.82%,RSD分别为0.02%~5.31%和0.01%~8.78%(n=9)。4类材质85批药包材样品中的TOC含量为0.35~17.29 mg/L。结论该方法操作简便,灵敏度和精密度好,方法重复性和准确度高,能快速检测不同材质药包材中TOC的含量。
Objective To establish a UV/persulfate wet oxidation non-dispersive infrared(NDIR)testing method for the content determination of total organic carbon(TOC)in the dissolved substances of different materials and different varieties(same materials)of pharmaceutical packaging materials.Methods A total of 85 batches of samples were collected from four types of materials:metal,plastic,rubber,and composite.The sodium persulfate(with a mass concentration of 80 g/L)was selected as the oxidant,the potassium hydrogen phthalate(KHP)and sucrose were used as standard substances,the response value of TOC was determined by the TOC analyzer,and the methodology was investigated by referring to the TOC determination method in pharmaceutical water in the 0862 of the Chinese Pharmacopoeia(Edition 2020,VolumeⅣ).Results The linear ranges of KHP and sucrose were 0.20-20.00 mg/L and 0.25-50.00 mg/L(r≥0.9999),respectively.The limit of detection(LOD)of the instrument was 33.11-34.30μg/L,and the limit of quantification(LOQ)of the instrument was 100.34-103.93μg/L.The RSD of the precision test was in the range of 0.16%-7.46%(n=6).The recoveries of KHP and sucrose were in the ranges of 91.37%-119.78%and 86.08%-121.82%,respectively,with RSDs of 0.02%-5.31%and 0.01%-8.78%(n=9),respectively.The TOC content in 85 batches of pharmaceutical packaging materials samples with four types of materials was in the range of 0.35-17.29 mg/L.Conclusion This method is simple,and has good sensitivity and precision,high repeatability and accuracy,which can quickly determine the content of TOC in different materials of pharmaceutical packaging materials.
作者
聂蕾
邓方
郑金梅
范钦源
聂晶
NIE Lei;DENG Fang;ZHENG Jinmei;FAN Qinyuan;NIE Jing(Yunnan Province Medical Instrument Testing Research Institute,Kunming,Yunnan 650106,China;Kunming Medical University,Kunming,Yunnan 650504,China;School of Pharmacy,Kunming Medical University Haiyuan College,Kunming,Yunnan 650106,China;Kunming Jida Pharmaceutical Co.,Ltd.,Kunming,Yunnan 650106,China)
出处
《中国药业》
2026年第1期78-82,共5页
China Pharmaceuticals
基金
云南省市场监督管理局2023年度科技计划项目[2023YSJK15]。
关键词
紫外/过硫酸盐湿法氧化非色散红外检测法
总有机碳
药品包装材料
溶出物
含量测定
UV/persulfate wet oxidation non-dispersive infrared testing method
total organic carbon
pharmaceutical packaging materials
dissolved substances
content determination
