Simultaneous Determination of Lovastatin and Lovastatin Acid in Hongqu Fuling Tablets by on Quantitative Analysis of Multi—Components by Single Marker(QAMS)

Objective: To establish a quantitative analysis of multi-components by single marker (QAMS) method for the determination of lovastatin and lovastatin acid for the quality control of Hongqu Fuling tablets. Methods: Lovastatin as a control, the RP-HPLC method was used to establish the relationship between the correction factor of lovastatin and lovastatin acid, and to simultaneously quantify both lovastatin and lovastatin acid in the Hongqu Fuling tablets by QAMS. Results: The negative sample had no interference, the specificity of the sample detection method was good, the linear relationship between lovastatin and lovastatin acid was good within the corresponding linear range, R²>0.9999, the precision and repeatability RSD values were less than 3%, and the recovery was 98.43%～103.18%. The relative correction factor of lovastatin acid and lovastatin was 0.9000, and the repeatability was good. The average content of lovastatin acid was 0.3563 mg/g determined by QAMS, and the average content of lovastatin acid determined by external standard method was 0.3668 mg/g, and the average content of lovastatin was 1.1113 mg/g, which indicated that the constructed QAMS method could be used for the multi-component quality evaluation research of Hongqu Fuling Tablets. Conclusion: The QAMS method established in this study was stable, accurate and specific, and would provide a scientific basis for the quality control and in-depth development of Hongqu Fuling tablets.