| 王鑫,刘宏大,薛雁,等.高效液相色谱法测定硫酸沙丁胺醇有关物质的含量[J].安徽医药,2020,24(2):242-246. |
| 高效液相色谱法测定硫酸沙丁胺醇有关物质的含量 |
| HPLC method was used to determine the content of albuterol sulfate |
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| DOI：10.3969/j.issn.1009?6469.2020.02.008 |
| 中文关键词: 沙丁胺醇/分析 药物污染 回收率 色谱法，高压液相 |
| 英文关键词: Albuterol/analysis Drug contamination Retrieving rate Chromatography,high pressure liquid |
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| 中文摘要: |
| 目的建立硫酸沙丁胺醇原料药有关物质的检测方法。方法采用高效液相色谱( HPLC)法测定。色谱柱为 HypersilGold C8柱( 250 mm×4.6 mm，3 μm)流动相 A为 3.45 g一水合磷酸二氢钠用 900 mL 0.05%的三乙酸胺溶液溶解，以稀磷酸调节 pH至 3.0之后用 0.05%的三乙酸胺溶，液定容至 1 000 mL；流动相 B为甲醇∶乙腈(体积比 20∶80)，进行梯度洗脱；流速为 1.0 mL/min，检测波长为 273 nm，柱温为 25 ℃。结果在该色谱条件下，硫酸沙丁胺醇及杂质 A、B、C、D、E、F、G、K、M、O、L、Q、I、J均能有效分离，分离度均大于 1.5；并且硫酸沙丁胺醇及杂质 C、D、F、M、O在 0.45~18.0 μg/mL内质量浓度与峰面积线性关系良好，回收率分别为杂质 C为 99.1%，RSD为 2.6%(n＝9)；杂质 D为 99.3%，RSD为 2.1%(n＝9)；杂质 F为 100.1%，RSD为 2.5%(n＝9)；杂质 M为 100.5%，RSD为 1.7%(n＝9)；杂质 O为 100.2%，RSD为 1.9%(n＝9)。结论该方法专属性强，适用于硫酸沙丁胺醇原料药有关物质检测。 |
| 英文摘要: |
| Objective To establish a method for detecting substances related to albuterol sulphate.Methods HPLC method was used for determination.Chromatographic column for Hypersil Gold C8 column(250 mm × 4.6 mm，3 microns)，A 3.45 g mobile phase monohydrate sodium dihydrogen phosphate，with 900 mL.Three acetic acid amine solution of 0.05%，with A dilute phosphoricacid to adjust pH to 3.0 after three acetic acid with 0.05% of the amine solution constant volume to 1 000 mL；the flow phase B is methanol∶acetonitrile(volume ratio 20∶80)，gradient elution；the velocity is 1.0 mL/min，the detection wavelength is 273 nm，and the column temperature is 25.Results In this chromatographic condition，salbutamol sulfate and impurities A，B，C，D，E，F，G，K， M，O，L，Q，I，J can be effectively separated，and the chromatographic resolution is greater than 1.5.In addition，salbutamol and impu? rities C，D，F，M and O are in good linear relationship with the peak area in 0.45%?18.0.The recovery rate of impurities C was 99.1%，and the RSD was 2.6 %(n＝9).The recovery rate of impurities D is 99.3%，and RSD is 2.1%(n＝9).The recovery rate of impurities F was 100.1%，RSD was 2.5%(n＝9).The recovery rate of impurities M was 100.5%，and RSD was 1.7%(n＝9).The recovery rate of impurities O was 100.2% and RSD was 1.9 %(n＝9).Conclusion This method has strong specificity and is suit? able for the detection of substances related to albuterol sulfate. |
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