2 results about "Stability indicating" patented technology

The application discloses an analysis method of tobramycin sulfate injection and application thereof, and the analysis method comprises the following steps: performing a pre-column derivatization reaction on a sample containing tobramycin and impurities by using a derivatization reagent, and then performing high performance liquid chromatography analysis on the sample after derivatization. The analysis is performed by gradient elution of a mobile phase A and a mobile phase B composed of water, acetonitrile and phosphoric acid, wherein the content of acetonitrile in the mobile phase B is higher than that in the mobile phase A, and effective separation of tobramycin and related impurities is realized by multi-stage gradient elution. The method can simultaneously separate and detect process impurities, degradation impurities and unknown impurities, has good separation degree and stability indicating capacity, and is suitable for quality control and drug stability research of tobramycin sulfate injection.

The invention discloses an analysis method for determining related substances in melogabalin besylate tablets, which establishes an analysis method with high detection sensitivity, high specificity, high accuracy and a stable indication effect by optimizing chromatographic conditions, optimizing the types of solvents and additives of mobile phases and adopting gradient elution. And good applicability and operability of the analysis method in the quality control application of the product are facilitated.