| 引用本文: | 晏海军,陈一波,张福利,林丽娅,王禄.HPLC测定盐酸氯胺酮原料药中的有关物质[J].中国现代应用药学,2022,39(5):633-637. |
| YAN Haijun,CHEN Yibo,ZHANG Fuli,LIN Liya,WANG Lu.Determination of the Related Substances in Ketamine Hydrochloride by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(5):633-637. |
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| HPLC测定盐酸氯胺酮原料药中的有关物质 |
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晏海军1,2, 陈一波2, 张福利2, 林丽娅2, 王禄3
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1.上海工程技术大学化学化工学院, 上海 201620;2.上海医药工业研究院有限公司, 上海 201203;3.国药集团工业有限公司廊坊分公司, 河北 廊坊 065000
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| 摘要: |
| 目的 建立HPLC检测盐酸氯胺酮原料药中有关物质的方法。方法 采用Waters Xbridge C18色谱柱，以0.005 mol·L-1己烷磺酸钠水溶液-乙腈-磷酸(90︰10︰0.1)为流动相A，乙腈为流动相B，梯度洗脱，流速1.0 mL·min–1，检测波长215 nm，柱温30 ℃。结果 主成分与各杂质间最小分离度>1.5；主成分以及其6个杂质在各自的浓度范围内呈良好的线性关系(r>0.999)；平均回收率为97.6%~103.0%，RSD为0.8%~2.8%。结论 本方法准确、灵敏、可靠，适用于盐酸氯胺酮有关物质的测定。 |
| 关键词: 盐酸氯胺酮 高效液相色谱法 有关物质 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.05.010 |
| 分类号:R917.101 |
| 基金项目: |
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| Determination of the Related Substances in Ketamine Hydrochloride by HPLC |
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YAN Haijun1,2, CHEN Yibo2, ZHANG Fuli2, LIN Liya2, WANG Lu3
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1.College of Chemistry and Chemical Engineering, Shanghai University of Engineering Science, Shanghai 201620, China;2.State Pharmaceutical Administration of Shanghai Institute of Pharmaceutical Industry, Shanghai 201203, China;3.China National Pharmaceutical Industry Corporation Ltd., Langfang Company, Langfang 065000, China
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| Abstract: |
| OBJECTIVE To establish an HPLC method for determination of the related substances in ketamine hydrochloride.METHODS Waters Xbridge C18 column was used; the mobile phase A consisted of 0.005 mol·L-1 sodium hexanesulfonate aqueous solution-acetonitrile-phosphoric acid (90︰10︰0.1), the mobile phase B was acetonitrile, with gradient elution at the flow rate of 1.0 mL·min-1; the detection wavelength was 215 nm; the column temperature was 30℃. RESULTS The minimum separation between the main component and each impurity was >1.5; ketamine and its six impurities showed a good linear relationship in the self-concentration range (r>0.999); and the average recoveries were 97.6%-103.0% with RSDs of 0.8%-2.8%. CONCLUSION The method is accurate, sensitive and reliable, which is suitable for the determination of related substances in ketamine hydrochloride. |
| Key words: ketamine hydrochloride HPLC related substance |
