摘要
目的建立金莲花胶囊高效液相色谱(HPLC)指纹图谱,为其质量评价提供依据。方法采用Phenomenex Gemini 5u C_(18) 110A色谱柱(250 mm×4.6 mm,5μm),检测波长为230 nm,以乙腈-水(含0.1%磷酸)为流动相梯度洗脱,流速为1.0 mL/min,柱温为35℃,进样量为10μL。测定17批金莲花胶囊,应用相似度分析软件建立金莲花胶囊共有模式,并对色谱峰进行指认。结果成功建立了金莲花胶囊HPLC指纹图谱,共标定23个共有峰,指认了4个色谱峰。结论建立的HPLC指纹图谱方法操作简便,重复性好,准确可靠,可为金莲花胶囊的质量控制提供依据。
Objective To establish an HPLC fingerprint of Jinlianhua Capsules and provide the basis for its quality evaluation. Methods The Phenomenex Gemini 5 u C_(18) 110 A column( 250 mm × 4. 6 mm,5 μm) was adopted with gradient elution by mixture of acetonitrile-water( 0. 1% phosphoric acid) as the mobile phase,the detection wavelength was 230 nm,the flow rate was 1. 0 mL/min,the column temperature was 35 ℃,and the sample size was 10 μL. The 17 batch of Jinlianhua Capsules were determined,and the common model was established by using the similarity analysis software,and the chromatographic peaks were identified. Results The HPLC-fingerprint of Jinlianhua Capsules was established and 4 out of the 23 common peaks in the fingerprint were identified. Conclusion The method has good precision,accuracy and reproducibility,which can be used for the quality control of Jinlianhua Capsules.
出处
《中国药业》
CAS
2018年第2期23-25,共3页
China Pharmaceuticals
基金
贵州省优秀青年科技人才培养对象专项资金项目[黔科合人字(2015)11号]
贵州省科技计划项目[黔科合平台人才(2016)5613
(2016)5677]
贵州省高等学校创新能力提升计划项目[黔教合协同创新字(2013)04]