HPLC测定注射用兰索拉唑中兰索拉唑的含量和有关物质

杨艳;谢俊霞;李冰;孙英华;方金玲;刘艳;何仲贵

中国药学杂志 ›› 2006, Vol. 41 ›› Issue (07) : 538-540.

中国药学杂志
中国药学杂志 ›› 2006, Vol. 41 ›› Issue (07) : 538-540.
论著

HPLC测定注射用兰索拉唑中兰索拉唑的含量和有关物质

  • 杨艳;谢俊霞;李冰;孙英华;方金玲;刘艳;何仲贵
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Determination of Lansoprazole and Its Related Substance in Lansoprazole for Injection by HPLC

  • ANG Yan， XIE Jun-xia， LI Bing， SUN Ying-hua， FANG Jin-ling， LIU Yan， HE Zhong-gui
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摘要

目的采用高效液相色谱法建立注射用兰索拉唑有关物质检查及其含量测定方法。方法Diamonsil-C18柱(4.6 mm×200 mm,5μm),以甲醇-水-三乙胺-磷酸(640∶360∶5∶1.5,pH为7.3)为流动相,检测波长为284 nm。结果制剂中辅料对主药测定无干扰,兰索拉唑与有关物质完全分离。在10.0～400.0 mg·L-1内峰面积与浓度呈良好的线性关系。精密度(RSD=0.13%)良好。平均回收率为99.6%。结论本方法简便,迅速,准确,专属性强。

Abstract

OBJECTIVE To establish a HPLC method for determing the content of lansoprazole and screening its related substance in lansoprazole for injection.METHODS A Diamonsil-C18 column(4.6 mm×200 mm,5 μm) was used.The mobile phase was methanol-water-triethylamine-phosphoric acid(640∶360∶5∶1.5,pH 7.3).The determination wavelength was 284 nm.RESULTS The excipients did not interfere with the determination of lansoprazole.Lansoprazole and its related substance were absolutely separated.The linear range of lansoprazole was 10.0～400.0 mg·L-1.The precision of the method(RSD=0.13%)was good.The average recovery was 99.6%.CONCLUSION The method is simple,speedy,accurate and specific.

关键词

高效液相色谱法 / 注射用兰索拉唑 / 含量测定 / 有关物质

Key words

HPLC / lansoprazole for injection / determination / related substance

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杨艳;谢俊霞;李冰;孙英华;方金玲;刘艳;何仲贵. HPLC测定注射用兰索拉唑中兰索拉唑的含量和有关物质[J]. 中国药学杂志, 2006, 41(07): 538-540
NG Yn;XIE Jun-xi;LI ing;SUN Ying-hu;FNG Jin-ling;LIU Yn;HE Zhong-gui. Determination of Lansoprazole and Its Related Substance in Lansoprazole for Injection by HPLC [J]. Chinese Pharmaceutical Journal, 2006, 41(07): 538-540

参考文献

[1] LIN B. Determination of lansoprazole in the raw material and its tablets by RP-HPLC[J] .Acad J Guangdong Coll Pharm(广东药学院学报)，1998，14 (4)：247-249. [2] KAROL M D， GRANNEMAN G R，ALEXANDER K. Determination of lansoprazole and five metabolites in plasma by high-performance liquid chromatography[J] . J Chromatography B，668(1995)：182-186. [3] YANG Y N，YU H X， LI Q N，et al. Stability of lansoprazole and lansoprazole tablets[J] .Chin J Mod Appl Pharm(中国现代应用药学)，2003，20(3)：203-205. [4] ChP（2000）VolⅡ（中国药典2000年版.二部）[S] .2000. [5] ALBIN K， FRANC V. Preformulation investigation of the novel proton pump inhibitor lansoprazole[J] . Drug Development and Industrial Pharmacy，26(7)：781-783(2000).

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