Study On The Methodology Of Determination Of Potassium Sodium Pehydroandro And Rographolide Succinate By HPLC

Potassium sodium pehydroandroandrographolide succinate which has strong antiviral activity is the herba andrographitis extract. Its dosage from only has potassium sodium dehydroandrographolide succinate for injection till this research finished. This paper is trying to establish a method to control the quality of potassium sodium dehydroandrographolide succinate for injection.According to the methods which has been found, the UV method has been used to determine potassium sodium pehydroandroandrographolide succinate in the paper. The average recovery is in the range of 99.5%-100% with average RSD(0.19%). The result shows that the determination by UV is accurate and convenient, but the UV method does not suit the qualification of material drug in unconventionality conditions in which andrographolide will be produced to interfere the determination. So the study on the drug with HPLC method has been taken in the work.Five mobile phase conditions which have good effects are chosen to use in the system suitability experiment. The result shows that the effect of methanol- 0.05%potassium dihydrogen phosphate (PH2.5±0.05)(70:30) is the best: theoretical plate number is 4812, resolution is 2.75, RSD=0.18%(n=10). The best mobile phase condition has been used to determine the Potassium sodium pehydroandroandrographolide succinate. The average value of repeat experiment is 103.16%,RSD=0.16%(n=6). The calibration curve was linear (r=0.9994) (n=6) within the range of 40-300μg?ml-1 for potassium sodium dehydroandrographolide succinate ,the mean recovery was 99.84% with RSD(0.32%).The result of different batches of the drug is in the range of 99.37%-100.31% (RSD=0.38%),which meets the needs of HPLC method criterion. According to the destructive experiment, this method can separate the potassium sodium dehydroandrographolide succinate and its related impurity and can be used as the base of determination on potassium sodium pehydroandroandrographolide succinate.Using the same HPLC method condition on potassium sodium dehydroandrographolide succinate for injection, the excipients have no notable interferer because it's HPLC peak is out of the determination range. The minimum detectability is 0.0056μg·ml-1 shows that the method can determine this dosage form accurately and precisely. The calibration curve was linear (r=0.9995,n=6) within the...