ABSTRACT
OBJECTIVE：To establish the fingerprint of Jingu tongxiao pill ，and to determine the contents of 7 components. METHODS：HPLC method was adopted. The determination was performed on Cosmosil 5C18-MS-Ⅱ column with acetonitrile- 0.02％ phosphoric acid solution as mobile phase （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelength was 230 nm and the column temperature was set at 25 ℃. The sample size was 10 μL. HPLC fingerprint of 10 batches of Jingu tongxiao pill was established by using Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition），and common peak was identified by comparing with the mixed reference substance. The contents of corresponding components of the identified common peak were determined by the same HPLC method. RESULTS ：There were 20 common peaks in HPLC fingerprint of 10 batches of samples ，and the similarity with the control fingerprint was not less than 0.980. By comparing with the mixed reference substance， 7 components were identified ， which were loganic acid ，gentiopicroside，paeoniflorin，salvianolic acid B ， cryptotanshinone，tanshinone Ⅰ and tanshinone Ⅱ A. The linear range of the above 7 components were 4.509-45.090， 15.090-150.900，14.985-149.850，14.982-149.820，2.967-29.670，1.944-19.440，3.094-30.940 μg/mL（all r＞0.999），respectively. The limits of detection were 0.060 1，0.161 0，0.399 6，0.159 8，0.031 6，0.051 8，0.082 5 μg/mL，respectively. The limits of quantitation were 0.200 4，0.503 0，0.999 0，0.399 5，0.079 1，0.259 2，0.412 6 μg/mL，respectively. RSDs of precision ，stability （24 h） and reproducibility tests were all lower than 3.0％ （n＝6）. Average recoveries were 98.81％ -100.28％ ，RSDs were 0.20％-1.21％（n＝6）. In 10 batches of samples ，the contents of the above 7 components were 0.441 0-0.969 4，3.283 4-4.733 4， 1.947 7-3.674 9，1.336 6-2.270 9，0.293 2-0.372 1，0.190 2-0.293 9 and 0.352 8-0.518 8 mg/g，respectively. CONCLUSIONS ：In this study，HPLC fingerprint and content determination method of Jingu tongxiao pill are successfully established and can be used for quality control.