Simultaneous Determination of Three Effective Components in Shugan Zhitong Tablets by HPLC
LV Yue,TANG Yong,LI Li-yan
Department of Pharmacy, Tianjin Nankai Hospital, Tianjin (300100), China
Abstract:
Objective To establish a method of HPLC for simultaneous determination of three effective components in Shugan Zhitong Tablets. Methods According to the methods contained in the 2015 edition of Chinese Pharmacopoeia, a method of HPLC for simultaneous determination of paeoniflorin, hesperidin and saikosaponin in Shugan Zhitong Tablets was established and verified by methodology. The determination was performed on WondaSil C18 column (4.6 mm×250 mm, 5 μm) with mobile phase consisted of 0.3% phosphoric acid aqueous solution (A)-acetonitrile (B). The column temperature was 38 ℃ , the flow rate was 1.0 mL/min, and the detection wavelengths were 230 nm (paeoniflorin), 254 nm (saikosaponin) and 283nm (hesperidin), respectively. Results The experimental results showed that the method had good specificity and the separation degree of each component was good. Paeoniflorin, saikosaponin and hesperidin had good linear relationship in the corresponding concentration range, the correlation coefficient (r) was not less than 0.9990, and the RSD calculated by precision experiment was less than 2%; the recovery rate of sample addition was in the range of 95%–105%. The repeatability and stability of the method met the requirements of the 2015 edition of Chinese Pharmacopoeia. Conclusion The established HPLC method for simultaneous determination of paeoniflorin, saikosaponin and hesperidin in Shugan Zhitong Tablets is verified by the method of prescription law, and meets the requirements of the verification guiding principles of drug quality standard analysis methods in the 2015 edition of Chinese Pharmacopoeia (4 parts 9101). Therefore, this method can be used to determine the content of paeoniflorin, saikosaponin and hesperidin in Shugan Zhitong Tablets.
