ABSTRACT
Objective:To establish reverse-phase high-performance liquid chromatography and simultaneously determine gallic acid, methyl gallate, corilagin, Sennoside B, and Sennoside A levels in Sana preparations.Methods:From January to December 2021, Phenomenex Hydro-RP 80A column (4.60 mm × 250 mm, 4 μm) was used. Elution was conducted using mobile phases methanol (A)-0.2% formic acid (B). The following gradients were applied: 1%-3%A for 0-18 minutes, 3%-15%A for 18-19 minutes, 15%-17%A for 19-40 minutes, 17%-25%A for 40-45 minutes, 25%-35%A for 45-65 minutes, 35%-60%A for 65-95 minutes, 60%-90%A for 95-96 minutes, 90%-1%A for 96-97 minutes. The flow rate was 1.0 mL/minute. The column temperature was 35 ℃. The detection wavelength was 270 nm.Results:The linear ranges of gallic acid, methyl gallate, corilagin, Sennoside B and Sennoside A were 0.182-1.099 μg ( r = 0.999 9), 0.046-0.278 μg ( r = 0.999 2), 0.266-1.598 μg ( r = 0.999 4), 0.172-1.036 μg ( r = 0.999 2), and 0.176-1.056 μg ( r = 0.999 9). The average dosing recovery rates were 100.02%, 99.14%, 99.38%, 101.77%, and 100.92%, respectively. Conclusion:Reverse-phase high-performance liquid chromatography can be used for quality control of Sana preparations because of high accuracy, sensitivity, reliability, and reproduction.