| 引用本文: | 林丽琴,杨直,石云峰.HPLC测定泛酸钙的有关物质[J].中国现代应用药学,2012,29(11):1035-1038. |
| LIN Liqin,YANG Zhi,SHI Yunfeng.Determination of the Related Substances of Calcium Pantothenate by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2012,29(11):1035-1038. |
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| 摘要: |
| 目的 建立高效液相色谱法测定泛酸钙的有关物质。方法 用十八烷基硅烷键合硅胶为填充剂；以磷酸盐缓冲液(取磷酸二氢钾8.34 g与磷酸氢二钾0.87 g，加水1 000 mL溶解，用磷酸调节pH值至5.7)为流动相；检测波长为205 nm。结果 杂质峰与主峰能够得到有效的分离，特殊杂质泛解酸的最低检出限为1.33 ng，最低定量限为4.42 ng；3批泛酸钙样品经检测泛解酸含量分别为0.234%，0.222%，0.234%，其他总杂质分别为0.168%，0.165%，0.157%。结论 该方法准确可靠，能有效检测出泛酸钙中的有关物质。 |
| 关键词: 泛酸钙 高效液相色谱法 有关物质 |
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| Determination of the Related Substances of Calcium Pantothenate by HPLC |
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LIN Liqin1, YANG Zhi1, SHI Yunfeng2
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1.Hangzhou Institute for Drug Control, Hangzhou 310017, China;2.Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China
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| Abstract: |
| OBJECTIVE To establish a method for determination of the related substances of calcium pantothenate by HPLC. METHODS A C18 column was used. The mobile phase was phosphate buffer solution composed of 8.34 g KH2PO4 and 0.87 g K2HPO4 in 1 000 mL water which pH was 5.7 adjusted by phosphoric acid. The wavelength was 205 nm. RESULTS The resolution of calcium pantothenate and relate substances was good. The limit of detection of pantoic acid which was the special impurity was 1.33 ng, and the limit of quantitation of it was 4.42 ng. The related substances of three batches of calcium pantothenate were detected, and the contents of the pantoic acid were 0.234%, 0.222% and 0.234%, and the contents of other related substances were 0.168%, 0.165% and 0.157%. CONCLUSION The method is accurate and reliable, and could be applied to determine the related substances of calcium pantothenate. |
| Key words: calcium pantothenate HPLC related substances |
