Fingerprint Analysis of Xiaoaiping Injection and Simultaneous Determination of Its Seven Active Steroidal Components in Xiaoaiping Injection by HPLC-ELSDChinese Full TextEnglish Full Text (MT)
GONG Xiao-bin;ZENG Qing-hua;ZHANG Feng;GAO Shou-hong;LU Wen-quan;CHEN Wan-sheng;Department of Pharmacy,Changzheng Hospital,Second Military Medical University;Guangxi Institute For Food And Drug Control;
Abstract: Objective: To develop and validate a high performance liquid chromatography coupled with evaporative light scattering detector（ HPLC-ELSD） method for the quantitative determination and fingerprint analysis of 7 active steroidal components in Xiaoaiping injection. Method: Chromatographic separation was performed on an Eclipse XDB-C18column（ 4. 6 mm × 250 mm,5 μm） by gradient elution using acetic acid in acetonitrile solution at a flow rate of 0. 8 m L·min- 1. The drift tube temperature of ELSD was set to 60 ℃ and nebulizer gas pressure was 0. 4 MPa. Method validation was performed to assure its linearity,limits of detection and quantification,precision,repeatability,stability and accuracy. Result: Fingerprint analysis obtained 13 common peaks in Xiaoaiping injection,and the similarity was higher than 0. 94. The HPLC-ELSD method allowed the quantification of 7 compounds（ 17β-tenacigenin B,tenacigenin B,tenacigenin A,tenacigenoside A,marsdenoside I and tenacissoside F）,and was successfully applied to fingerprint analysis for 11 batches of Xiaoaiping injection.Conclusion: It was the first time to apply HPLC-ELSD for simultaneous determination of 7 active ingredients and fingerprint analysis of Xiaoaiping injection. The results proved the reliability and comprehensiveness of the combination of quantitative analysis for marker ingredients and chemical fingerprint for TCM formula.
- DOI：
10.13422/j.cnki.syfjx.2016150068
- Series：
- Subject：
- Classification Code：
R286.0;O657.72
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