Study of Determination of Rutecarpine in Aifunuangong Capsule

OBJECTIVE Setting the method of measuring the content of Rutecarpine by using highly-effective liquid chromatography. METHODS Choosing proper stationary phase and adjusting the components, proportion, flow rate of mobile phase and column temperature in the condition of wavelength (nm) max to make theoretical plate number meet the standard. Preparing reference substance solution of different concentration, performing linear regression with chromatographic peak area as y-axis and sampling concentration as x-axis to get curvilinear regression and investigating linearity range. Investigating precision, ruggedness, stability and sample recovery rate of the method. Determining the content of components in three batches of samples according to the methods mentioned above. RESULTS The concentration of rutaecarpin was determined using a HPLC system at the wavelength of 345 nm. The separation was achieved by using a Thermo column (200 mm×4.6 mm, 5 μm), at a rate of 0.8 mL·min^-1. The temperature of column was 25 ℃. The mobile phase consisted of 0.04% octane sodium alkane sulphonate and acetonitrile at a ratio of 45∶55, with a good linear relationship among 8.52-85.2 μg·mL^-1, r is 0.999 8. The RSD% of precision, precision in middle, durable property, reproducibility, the stability within 12 hours and analytical recovery were 0.37%, 0.87%, 1.02%, 1.34%, 1.24%, 0.41%, respectively. The analytical recovery was 99.6%. It was no less than 0.067mg in per granule of the content of Rutecarpine. CONCLUSION Regarding the accepted active ingredients as a target of determining the content, using highly-effective liquid chromatography to measure rutecarpine, has good accuracy, exdusivity repe atability and the method is able to ensure the quality.