摘要
目的通过对大环内酯类抗生素(克拉霉素,罗红霉素)对照品的纯度分析,探讨差示扫描量热法(Differential scanning calorimetry,DSC)在对照品纯度分析中的应用。方法结合DSC和高效液相色谱法(HPLC)分析大环内酯类抗生素(克拉霉素,罗红霉素)对照品量值情况,同时探究DSC进行纯度分析的适用性。结果克拉霉素、罗红霉素的DSC纯度分析和高效液相色谱纯度分析结果分别为99.9%和100.0%,99.8%和100.0%,二者无明显差异。结论DSC能够很好地适用于大环内酯类抗生素(克拉霉素,罗红霉素)对照品的纯度分析,该研究结果有助于推进热分析技术在某些抗生素对照品纯度分析中的应用。
Objective To explore the application of differential scanning calorimetry(DSC)in the purity analysis of macrolide antibiotics reference substances such as clarithromycin and roxithromycin.Methods The DSC method and high performance liquid chromatography(HPLC)were used to analyze the values of macrolide antibiotics reference substances,and the applicability of DSC was also studied by means of thermogravimetric analysis(TGA).Results The purities of clarithromycin and roxithromycin determined by DSC and HPLC were 99.9%and 100.0%,99.8%and 100.0%,respectively,without significant differences.Conclusion DSC is particularly suitable for purity analysis of macrolide antibiotic reference substances,and this study would actively promote the application of thermal analysis technology in the field of quality control of antibiotics reference substances.
作者
翟铁伟
ZHAI Tie-wei(Food and Drug Audit and Inspection Center,State Drug Administration,Beijing 100044,China)
出处
《实用药物与临床》
CAS
2019年第11期1178-1181,共4页
Practical Pharmacy and Clinical Remedies
关键词
差示扫描量热法
大环内酯类抗生素
对照品
纯度分析
Differential scanning calorimetry
Macrolide antibiotics
Reference substances
Purity analysis
