An HPLC-QAMS method for simultaneous determination of ten components in Compound Jinpu Tablet for quality control / 国际药学研究杂志

ABSTRACT

Objective: To develop an HPLC method for quantitative analysis of multi- components by single marker(QAMS)to simultaneously determine gypenoside XL,gypenoside A, gypenoside X,danshensu,salvianolic acid B,tanshinone Ⅱ A,orientin,isoorientin,vitexin and isovitexin in Compound Jinpu Tablet(CJT). Methods: HPLC was performed on a Wondasil C18 column(250 mm×4.6 mm,5 μm)at 30℃. The mobile phase was methanol-aceto-nitrile(31)and 0.1% formic acid aqueous solution,in a gradient elution,and the flow rate was 0.9 ml/min. The detec-tion wavelength was set at 203 nm for gypenoside XL,gypenoside A and gypenoside X,280 nm for danshensu,sal- vianolic acid B and tanshinoneⅡA,and 340 nm for orientin,isoorientin,vitexin and isovitexin. The content of the ten components in CJT was determined at first by the external standard method(ESM)using ten related standards. For the QAMS method,only tanshinone ⅡA was used as an internal standard,whereas the relative correction factors of the other nine components in CJT were determined using the internal tanshinone ⅡA as reference standard,and their content was calculated on the basis of the correction factors and the tanshinone ⅡA content determined by ESM. The QAMS method was validated by comparison of the calculated values with the measured data by ESM. Results: The 10 components all showed a good linearity within the concentration ranges of 2.848-56.96,5.304-106.08,7.776-155.52,1.248-24.96, 13.28-265.6,1.976-39.52,1.112-22.24,0.928-18.56,0.696-13.92,and 0.648-12.96 μg/ml(r≥0.9992),with the average recoveries(RSDs)of 99.35%(0.97%),99.07%(1.10%),98.81%(0.83%),97.69%(1.39%),100.05%(0.79%),97.90%(1.20%),98.21%(1.52%),97.59%(1.44%),96.93%(1.07%)and 96.99%(0.89%),respectively. No significant differences were found in the content of the nine components in CJT between the QAMS-calculated values and the ESM-measured data. Conclusion: The established QAMS method could simultaneously determine multi-compo- nents using only one standard. It is simple and accurate,which could be used for simultaneous determination of the con- tent of ten components in CJT.