Su Hong, Wang Ai-min, Wang Yong-lin, Lan Yan-yu, He Xun, Li Yong-jun
School of Pharmacy, Guiyang Medical College, Guiyang 550004, China.
Zhongguo Zhong Yao Za Zhi. 2007 Aug;32(15):1515-7.
To establish the fingerprint detecting standard of xinshao Injection by reversed phase high performance liquid chromatography.
The chromatographic conditions were as follows: an Diamonsil C18 column was used, the mobile phase was composed of 80% acetontrile and 0.1% phosphoric acid with gradient elution, the flow rate 1.0 mL min(-1), column temperature was 40 degrees and the UV absorbance detection was set at 230 nm.
A standard HPLC fingerprint procedure was developed for xinshao Injection, with 8 common peaks. Under the same selected chromatographic conditions, the HPLC fingerprints of raw drugs and their intermediate, finished products were obtained with good separation and correlation (no less than 0.97) according to the technical requirements of fingerprint on Injection of Chinese traditional medicine.
This method was accurate, repeatable and can be used as the important parameters of the quality control for xinshao injection.
采用反相高效液相色谱法建立新癀注射液指纹图谱检测标准。
色谱条件如下:使用迪马C18柱,流动相由80%乙腈和0.1%磷酸组成,梯度洗脱,流速1.0 mL·min⁻¹,柱温40℃,紫外吸收检测波长设定为230 nm。
建立了新癀注射液的标准HPLC指纹图谱,共有8个共有峰。在相同选定的色谱条件下,按照中药注射剂指纹图谱技术要求,获得了原料药及其中间体、成品的HPLC指纹图谱,分离度良好且相关性良好(不低于0.97)。
该方法准确、可重复,可作为新癀注射液质量控制的重要参数。