Quality control standard for Qingre Baidu granules

VernacularTitle:清热败毒颗粒剂的质量标准研究
Author: Tianyi XIA ¹ ; Bing ZHANG ; Shouhong GAO ; Wenquan LU ; Shujuan PIAO ; Tao PANG
Author Information

1. 第二军医大学长征医院药学部
Keywords: HPLC; TLC; chlorogenic acid; Qingre Baidu granules
From: Journal of Pharmaceutical Practice 2016;34(5):450-454
CountryChina
Language:Chinese
Abstract: Objective To establish a quality control standard for Qingre Baidu granules .Methods Isatidis Radix ,Fruc-tus Forsythiae ,Herba Violae ,and Glycyrrhizae were identified by TLC ,and the concentration of chlorogenic acid was deter-minedbyHPLC.ThismethodwasemployedonanAgilentZORBAXSB-C18column(4.6mm×250mm,5μm)at30℃ witha mobile phase of acetonitrile (A) and 0 .2% formic acid (B) using the gradient elution program shown as follows :0-12 min , 11%-12% A run at the flow rate of 1 .0 ml/min .The injection volume was 20 μl and the detection wavelength was 327 nm . Results Characteristic spots could be detected by TLC and the specificity of the method was satisfactory .As for chlorogenic acid ,the equation of linear regression of chlorogenic acid was Y=60 .239 4X+9 .096 3 (r=0 .999 9) with the linear range of 6.19-396 .00 μg/ml .The average recovery was 99 .66% (RSD=2 .82% ) .Conclusion The established method is simple ,reli-able ,reproducible ,and can be used for the quantitative determination and quality control of Qingre Baidu granules .