Quality control standard for Qingre Baidu granules

XIA Tianyi; ZHANG Bing; GAO Shouhong; LU Wenquan; PIAO Shujuan; PANG Tao

doi:10.3969/j.issn.1006-0111.2016.05.018

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Objective To establish a quality control standard for Qingre Baidu granules. Methods Isatidis Radix, Fructus Forsythiae,Herba Violae, and Glycyrrhizae were identified by TLC, and the concentration of chlorogenic acid was determined by HPLC. This method was employed on an Agilent ZORBAX SB-C₁₈column (4.6 mm×250 mm, 5 μm) at 30℃ with a 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, reliable, reproducible, and can be used for the quantitative determination and quality control of Qingre Baidu granules.

Quality control standard for Qingre Baidu granules

1. Department of Pharmacy, Changzheng Hospital, Second Military Medical University, Shanghai 200433, China

2. Pharmacy of Clinic, Retired Navy Officer Home, Shuidian Road, Shanghai 200083, China

Received Date: 2015-03-06

Rev Recd Date: 2015-06-28

Key words:

Abstract: Objective To establish a quality control standard for Qingre Baidu granules. Methods Isatidis Radix, Fructus Forsythiae,Herba Violae, and Glycyrrhizae were identified by TLC, and the concentration of chlorogenic acid was determined by HPLC. This method was employed on an Agilent ZORBAX SB-C₁₈column (4.6 mm×250 mm, 5 μm) at 30℃ with a 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, reliable, reproducible, and can be used for the quantitative determination and quality control of Qingre Baidu granules.

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Reference (9)

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Quality control standard for Qingre Baidu granules

doi: 10.3969/j.issn.1006-0111.2016.05.018

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通讯作者: 陈斌, [email protected]

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