| 引用本文: | 闫凯,孙婷,袁坤,赵冬,王少博,生丽丹,刘雪莉,朱嘉亮.一种新型抗病毒药玛巴洛沙韦酯原料及制剂含量测定方法研究 [J].中国现代应用药学,2025,42(1):37-40. |
| yankai,Sun Ting,yuankun,zhaodong,Wangshaobo,shenglidan,liuxueli,zhujialiang.Determination of raw materials and preparations of a new antiviral drug of Mabaloxavixate[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(1):37-40. |
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| 一种新型抗病毒药玛巴洛沙韦酯原料及制剂含量测定方法研究 |
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闫凯,孙婷,袁坤,赵冬,王少博,生丽丹,刘雪莉,朱嘉亮
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1.河北省药品医疗器械检验研究院;2.石家庄市中医院;3.石药集团中奇制药技术石家庄有限公司;4.中国食品药品检定研究院
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| 摘要: |
| 目的 建立玛巴洛沙韦酯原料及片剂的含量测定方法。方法 采用HPLC法对原料药及制剂的含量进行测定,所用色谱柱为SYMC-Triart C18 ExRS(250 mm×4.6 mm,5μm),柱温30℃；以0.1%磷酸水溶液-乙腈-甲醇(30:35:35)为流动性,流速：1.0 ml.min-1,检测波长：259nm。结果 主峰与辅料和各杂质峰分离度良好,方法的专属性良好,在198.499mg/ml～595.498μg/ml浓度范围内,峰面积与浓度线性关系良好,r为0.9997, 99.80%～100.55%之间,平均回收率为100.3%,RSD为0.3%。结论 建立的方法具合理性、准确性和专属性,可用于巴洛沙韦酯原料及其片剂的有关物质测定。 |
| 关键词: 巴洛沙韦 含量测定 液相色谱 |
| DOI： |
| 分类号:R284.1；R917.101 |
| 基金项目: |
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| Determination of raw materials and preparations of a new antiviral drug of Mabaloxavixate |
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yankai1, Sun Ting2, yuankun3, zhaodong1, Wangshaobo4, shenglidan4, liuxueli1, zhujialiang5
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1.Hebei Institute for drug and Medical Device Control;2.Hebei institute for drug control;3.Shijiazhuang Traditional Chinese Medicine Hospital;4.Zhongqi Pharmaceutical Technology(SJZ) CO., LTD.,;5.National Institutes for Food and Drug Control
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| Abstract: |
| ABSTRACT: OBJECTIVE Establish a high performance liquid chromatography method to detect baloxavir dipivoxil API and its tablets. METHODS The contents of baloxavir dipivoxil was tetermined by HPLC. The column was SYMC-Triart C18 ExRS（250 mm×4.6 mm，5μm）the mobile phase was 0.1% phosphoric acid- acetonitrile-methyl（30:35:35）; he column temperature was 30 ℃, the flow rate was 1.0 mL·min-1,the detection wavelength was 259nm. RESULTS In the concentration range of 198.499g/ml ~ 595.498μg/ml, the linear relationship between the peak area and the concentration was good, and the r was 0.9997, 99.80% ~ 100.55%, the average recovery was 100.3%, and the RSD was 0.3%. CONCLUSION The method is simple, robust, and can be used for the determination of baloxavir dipivoxil and its tablets.KEY WORDS: keyword1; keyword2; keyword baloxavir dipivoxil; contents; liquid chromatography |
| Key words: baloxavir dipivoxil contents liquid chromatography |
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