Content Determination of Multiple Indexes in Zhengxin Jiangzhi Tablets and Cluster Heatmap Analysis / 中国药房

ABSTRACT

OBJECTIVE：To establish the method for the content determination of 7 components，such as puerarin ， 3′-methoxypuerarin，daidzein，rutin，hesperidin，salvianolic acid A and quercetin ，in Zhengxin jiangzhi tablets ，and conduct cluster heatmap analysis. METHODS ：HPLC method was adopted. The separation was performed on Kromasil C 18 column with mobile phase consisted of acetonitrile- 0.1％ formic acid solution （gradient elution ）at the flow rate of 0.8 mL/min. The detection wavelength was set at 280 nm，and the column temperature was 25 ℃. The sample size was 10 μL. Taking the content data as the object，the cluster heatmap was drawn by Hiplot scientific research mapping platform. RESULTS ：The linear range of puerarin ， 3′-methoxypuerarin，daidzein，rutin，hesperidin，salvianolic acid A and quercetin were 17.00-170.00（r＝0.999 9），5.14-51.40（r＝ 0.999 8），3.00-30.00（r＝0.999 8），153.00-1 530.00（r＝0.999 9），7.88-78.75（r＝0.999 8），2.85-28.50（r＝0.999 9）and 11.34-113.40 μg/mL（r＝0.999 8），respectively. RSDs of precision ，stability（24 h）and repeatability tests were all less than 2％； the average recoveries were 99.58％（RSD＝0.83％，n＝6），100.31％（RSD＝1.17％，n＝6），100.61％（RSD＝1.08％，n＝6）， 100.05％（RSD＝0.82％，n＝6），100.31％（RSD＝1.38％，n＝6），100.31％（RSD＝0.85％，n＝6），99.85％（RSD＝1.01％， n＝6），respectively. The contents of above components in 10 batches of samples were 7.262 5-8.941 5，2.464 9-3.068 9，1.478 9- 1.883 4，58.632 8-79.408 3，3.569 4-4.500 6，1.077 6-1.341 5，1.139 7-5.957 0 mg/g，respectively. Results of cluster heatmap analysis showed that 10 batches of samples could be divided into 4 categories，including S 1-S3 as one category ，S4 as one category，S5-S6 as one category and S 7-S10 as one category. CONCLUSIONS ：The established method is simple ，accurate and specific，which can be used for the quality control of Zhengxin jiangzhi tablets ，combined with cluster heatmap analysis. There are some differences in the quality of different batches of samples.