差示扫描量热分析法测定米力农药物的纯度.pdf

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化学世界
2012年
差示扫描量热分析法测定米力农药物的纯度
王防,涂强',李意,王维2
(1.南京师范大学分析测试中心,江苏南京210046;2.南京晓庄学院化学系,江苏南京210028)
摘要:运用差示扫描量热(DSC)法,测定了米カ农药物的纯度,计算和分析了不同质量的药物试
样以及试样在不同升温速率下,其纯度值的差异,并与高效液相色谱法( HPLC)的测定结果进行了
比较。结果表明:两种方法结果相差0.03%,基本一致;药物试样精密度测定结果平均值为
99.957%,RSD为0.01%;测定不同质量的药物试样,其纯度値最大相差0.077%;不同升温速率
下,药物试样的纯度値最大相差0.186%。DSC方法可以用作为测定药品纯度的补充方法。
关键词:差示扫描量热法;高效液相色谱法;纯度;米力农
中图分类号:O657.99
文献标志码:A
文章编号:0367-6358(2012)06-0338-04
Measure the Purity of Drug Milrinone by DSC
WANG Fang, TU Qiang, LI Yi, WANG Wei
(1. Testing & Analysis Center, Nanjing Normal University, Jiangsu Nanjing 210046, China,
2. Chemistry Deartment, Nanjing Xiaozhuang University, Jiangsu Nanjing 210028, China)
Abstract: The purity of drug milrinone was measured by Differential Scanning Calorimetry(DSC). The
results that were tested in different qualitys and at different heating rates were calculated and analysed
Meanwhile, the purity of sample milrinone was also tested by High Performance Lliquid Chromatography
( HPLC). We compared with their difference between using DSC and using HPLC. It showed that they are
the same approximately. DSC,s measurement is smaller than the HPLCS about O03%. The average
sample purity was 99.957% and its RSD was 0. 01% which were measured five times at the same tset
conditions. Maximum is 0.77% in different qualities while maximum is 0.186% at different heating rate.
It is available for DSC to measure the purity of drugs.
Key words: differential scanning calorimeter; purity; milrinone
纯度是衡量药物质量优劣的重要指标之ー门,谱法测得结果相吻合的。蒙根等人用DSC测定马
近年来,热分析技术被逐步应用于化学药品的鉴别、来酸酐的纯度,并同时用DSC、HPLC、药典法、滴定
理化常数测定、多晶及亚稳态、无定形态的研究、优法测定不同物质的纯度,比对4种方法结果基本
化冷冻干燥、吸附水与结晶水含量、赋形剂测试、药致。 Renate等利用DSC测定导眠能、辛可卡因
物组份间的相互作用等的研究25,人们也在不断地等药品的纯度。 Cabdace Plate等报道了用DSC法
探索与研究用DSC对药物的纯度进行考査与分析。测定95种有机物的纯度,其中包括酰胺类、杂环类、
杨腊虎等曾用DSC对膏蒿素及其衍生物的热行为脂类及卤化物等。 Slab用DSC等温方法测定了非
进行了研究,发现用DSC法测得结果与高效液相色拉西丁纯度(含不同量的苯甲跳胺杂质),并用动态
收稿日期:2012-01-04;修回目期:2012-06-27
甚金项?;江苏省高校自然科学基金项目(09KJD350001)
作者简介;王昉(1966-),女,福建莆田人,高级实验师。主要从事热分析及其相关分析方法的研究。 Email; wangfang@ nnu.edu,cn