舒肝宁注射液HPLC指纹图谱研究

张昀; 张艳萍; 何峰<sup>*</sup>

引用本文:	张昀,张艳萍,何峰.舒肝宁注射液HPLC指纹图谱研究[J].中国现代应用药学,2015,32(7):824-827.
	ZHANG Yun,ZHANG Yanping,HE Feng.Fingerprint Chromatography of Shuganning Injection by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(7):824-827.

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舒肝宁注射液HPLC指纹图谱研究
张昀¹, 张艳萍¹, 何峰²
1.贵州瑞和制药有限公司，贵阳 550004;2.贵阳医学院药学院，贵阳 550004

摘要:

目的建立舒肝宁注射液HPLC指纹图谱质量控制方法。方法色谱柱：ZORBAXSB-C₁₈(150 mm×4.6 mm，5 μm)，柱温：30 ℃；流动相：甲醇-0.05%磷酸溶液梯度洗脱；流速：1.0 mL·min^-1；检测波长：238 nm；进样量：5 μl。结果舒肝宁注射液各成分得到较好分离，以黄芩苷峰为参照物峰，确定了13个共有峰，20批舒肝宁注射液指纹图谱相似度均>0.998。结论本方法简便、稳定、重复性好，为舒肝宁注射液的质量控制提供了依据。

关键词: 舒肝宁注射液指纹图谱高效液相色谱法

DOI：

分类号:

基金项目:贵州省科技重大专项项目(黔科合重大专项字[2011]6019-05号)

Fingerprint Chromatography of Shuganning Injection by HPLC

ZHANG Yun¹, ZHANG Yanping¹, HE Feng²

1.Guizhou Ruihe Pharmaceutical Co., Ltd., Guiyang 550004, China;2.School of Pharmacy, Guiyang Medical College, Guiyang 550004, China

Abstract:

OBJECTIVE To establish a fingerprint method of analyzing Shuganning injection by HPLC. METHODS The chromatographic column was ZORBAXSB-C₁₈(150 mm×4.6 mm, 5 μm). The mobile phase consisted of Methanol-0.05% phosphoric acid was used with gradient elute at a flow rate of 1.0 ml·min^-1. The detection wavelength was at 238 nm, the column temperature was 30 ℃ and the injection volume was 5 μL. RESULTS According to the selected chromatographic conditions, 13 common peaks were obtained for standard fingerprint chromatography with baicalin peak as the reference peak. The similarity of 20 batches shuganning injection was not lower than 0.998. CONCLUSION This method was simple, accurate and sensitive which could be used to evaluate the quality of Shuganning injection.

Key words: Shuganning injection fingerprint chromatography HPLC