| HPLC测定萘敏维滴眼液中的有关物质 |
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| 引用本文： | 李欣,杨梅,陈红. HPLC测定萘敏维滴眼液中的有关物质[J]. 华西药学杂志, 2017, 32(5). DOI: 10.13375/j.cnki.wcjps.2017.05.030 |
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| 作者姓名： | 李欣 杨梅 陈红 |
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| 作者单位： | 成都市食品药品检验研究院,四川成都,610045 |
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| 摘 要： | 目的 采用HPLC法测定萘敏维滴眼液中的有关物质.方法 采用Hibar RP-C18色谱柱(250 mm×4.6 mm,5μm),梯度洗脱,流速1.0 mL· min-1,柱温30℃,检测波长223 nm,进样量50 μL.结果 在选定的色谱条件下,主成分与5种杂质的分离良好,线性范围为10 ～2×103ng·mL-1,最低检出限为0.04～0.85 ng.结论 所用方法专属性强、准确度高,可用于检查萘敏维滴眼液中的有关物质.
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| 关 键 词： | 高效液相色谱法 萘敏维滴眼液 盐酸萘甲唑啉 马来酸氯苯那敏 有关物质 梯度洗脱 检测限 质量控制 |
Determination of the related substances in Naphazoline hydrochloride,Chlorphenamine maleate and Vitamin B12 eye drops by HPLC |
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| LI Xin,YANG Mei,CHEN Hong. Determination of the related substances in Naphazoline hydrochloride,Chlorphenamine maleate and Vitamin B12 eye drops by HPLC[J]. West China Journal of Pharmaceutical Sciences, 2017, 32(5). DOI: 10.13375/j.cnki.wcjps.2017.05.030 |
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| Authors: | LI Xin YANG Mei CHEN Hong |
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| Abstract: | OBJECTIVE To establish an HPLC method to determine the related substances in Naphazoline hydrochloride,Chlorphenamine maleate and Vitamin B12 eye drops(NCVED).METHODS A Hibar RP-C1s column was used.Gradient elution was adopted and the detection wavelength was 223 nm with the flow rate of 1.0 mL· min-1.Column temperature was 30 ℃ and the injection volume was 50 μL.RESULTS Principal component was completely separated from five impurities.The linear ranges were 10-2 × 103 ng· mL-1,and the LOQs were 0.04-0.85 ng.CONCLUSION The method is specific,accurate and suitable for analyzing the related substances in NCVED. |
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| Keywords: | HPLC Naphazoline hydrochloride Chlorphenamine maleate and Vitamin B12 eye drops Naphazoline hydrochloride Chlorphenamine maleate Related substances Gradient elution Limits of detection Quality control |
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