Quality Analysis of Long dan Xie gan Pill by a Combination of Fingerprint and Multicomponent Quantification with Chemometrics Analysis.

Long dan Xie gan pill is a traditional complex compound preparation with a long history for treatment of diseases, including hepatocolic hygropyrexia, dizziness, tinnitus, and deafness. Quality of products from different manufacturers may be varied. Since the current standard could not control the quality of products in a comprehensive and effective way, this study aimed at establishing a practical and convenient approach for holistic quality control of the preparation. This study included both qualitative and quantitative works to get information on the overall composition and main components, respectively. As a result, HPLC fingerprint (UV 240 nm) similarities of all fifty samples were in the range of 0.65∼0.99. Results indicated that there was a difference among products from different manufacturers. Additionally, ten characteristic peaks of the fingerprint were tentatively identified by LC-MS. Further chemometrics analysis was utilized to evaluate the products from different manufacturers. At the same time, the HPLC (UV 285 nm) multicomponent quantification result showed that contents of gentiopicrin, baicalin, baicalein, and wogonin were in the range of 0.61-5.40, 1.96-5.33, 0.10-3.40, and 0.046-1.16 mg·g(-1), respectively. Data analysis verified the main different component of baicalein from the fingerprint statistical analysis. It is worth mentioning that the qualitative fingerprint and quantitative multicomponent determination were simultaneously accomplished by HPLC-DAD with dual channels. The study provided sound basis for improving quality control standards. This study also provided practical strategy for overall quality control of traditional Chinese medicines.