| 曹玉明.HPLC法测定糠酸莫米松乳膏中的有关物质[J].安徽医药,2016,20(5):870-873. |
| HPLC法测定糠酸莫米松乳膏中的有关物质 |
| Determination of the related substances in Mometasone Furoate Cream by HPLCCao Yu-ming (Anhui NHU Pharmaceutical Com.,Ltd,Xuancheng,Anhui 242000,China) Abstract:Objective |
| 投稿时间：2016-01-26 |
| DOI： |
| 中文关键词: 糠酸莫米松 色谱法,高压液相 |
| 英文关键词: Mometasone Furoate Cream Chromatography,High Pressure Liquid |
| 基金项目: |
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| 中文摘要: |
| 目的 建立糠酸莫米松乳膏(艾洛松)中有关物质的检测方法。 方法 采用HPLC法对艾洛松中的有关物质进行测定。以Amethyst C18-P(250 mm×4.6 mm,5 μm)色谱柱为固定相；乙腈-水(53∶47)为流动相；流速为1 mL·min-1；检测波长为254 nm；进样量为20 μL。 结果 各单个杂质不超过1.0%,总杂质不超过2.0%。该方法对5个批次糠酸莫米松乳膏中的有关物质进行了测定,其限度均为单个杂质不超过1.0%,总杂质不超过2.0%。 结论 该方法准确可靠,可作为糠酸莫米松乳膏(艾洛松)中有关物质的测定方法。 |
| 英文摘要: |
| Objective To develop a method for the related substances in mometasone furoate cream(Eloson). Methods HPLC was adopted for the limits determination of the related substances.An Amethyst C18-P column(250 mm × 4.6 mm,5 μm)was used as the stationary phase,with a mobile phase of acetonitrile-water solution(53∶47),the flow rate was 1 mL·min-1,the detection wavelength was 254 nm and the injection volume was 20 μL. Results For each impurity was not more than 1.0%,the total was not more than 2.0%.Five batches of Eloson were analyzed under the established method,all of results were that for each impurity was not more than 1.0% and the total was not more than 2.0%. Conclusion The developed method is accurate and reliable,which could be used for the limit control of the related substances in Eloson. |
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