吗多明片的含量及有关物质测定方法改进
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篇名: | 吗多明片的含量及有关物质测定方法改进 |
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摘要: | 目的:改进测定吗多明片含量及有关物质的方法。方法:采用高效液相色谱法测定吗多明片含量及有关物质,并采用高效液相色谱-质谱联用(HPLC-MS)法对破坏试验降解杂质进行定性。色谱柱为Waters Symmetry-C18,流动相为0.05%甲酸-甲醇(梯度洗脱),流速为1.0、0.2 ml/min(分别用于含量及有关物质测定、质谱分析),检测波长为210 nm,柱温为30 ℃,进样量为20、5 μl(分别用于含量及有关物质测定、质谱分析)。结果:该色谱条件下各组分之间分离度良好;降解杂质成分得到确认;吗多明检测质量浓度线性范围为4.0~28.0 μg/ml(r=0.999 7);精密度、稳定性、重复性试验的RSD<1%;吗多明加样回收率为97.74%~100.70%,RSD=0.49%(n=9)。结论:本方法简便、准确、专属性好、精密度高,可完善吗多明片的质量控制。 |
ABSTRACT: | OBJECTIVE:To improve the method for the determination of content and related substances of Molsidomine tablet. METHODS: HPLC was adopted to determine the content and related substances, HPLC-MS was adopted for the qualitative degradation impurities in destruction test. The column was Waters Symmetry-C18 with mobile phase of 0.05% formic acid - methanol (gradient elution) at a flow rate 1.0 ml/min and 0.2 ml/min (respectively for content and related substances determination, mass spectrometry), the detection wavelength was 210 nm, column temperature was 30 ℃, the injection volume was 20 μl and 5 μl (respectively for content and related substances determination, mass spectrometry). RESULTS:Each component was well separated under chromatographic conditions; degradation impurities were confirmed; the linear range of molsidomine was 4. 0-28.0 μg/ml (r=0.999 7); RSDs of precision, stability and reproducibility tests were lower than 1%; recovery was 97.74%-100.70% (RSD=0.49%,n=9). CONCLUSIONS: The method is simple, accurate with good specific and high precision, and can improve the quality control of Molsidomine tablet. |
期刊: | 2016年第27卷第12期 |
作者: | 韩淑芹,白晓杰 |
AUTHORS: | HAN Shuqin,BAI Xiaojie |
关键字: | 吗多明片;高效液相色谱法;质谱法;含量;有关物质 |
KEYWORDS: | Molsidomine tablet; HPLC; MS; Content; Related substance |
阅读数: | 387 次 |
本月下载数: | 2 次 |
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