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The chromatographic conditions and system suitability test

With cyano chemically bonded silica as the filling agent; Containing 0.25% (ml/ml) of triethylamine 0.05 mol/L sodium acetate solution (with glacial acetic acid to adjust pH value to 6.0) - methanol (50:50) as mobile phase; Detection wavelength of 302 nm. Theoretical plate number calculated by hydrochloric acid gamla SiQiong peak not less than 2000. The right amount of hydrochloric acid gamla SiQiong, adding solvent (take phosphate 0.16 ml to 80 ml of water, add acetonitrile 20 ml, blender, add hexyl amine 0.1 ml, with triethylamine adjust pH value to 7.5) dissolve and dilution is made in each 1 ml solution containing about 0.5 mg, apply adequate amount, place a test tube, plug, under the strong light irradiation for 4 hours, take 20 mu l injection liquid chromatograph, record chromatograph chart, hydrochloric acid granite SiQiong peak should produce obvious light degradation products before peak, hydrochloric acid and light degradation products gamla SiQiong peak separation degree should comply with the requirements.

About the material

Gamla SiQiong hydrochloride, and dissolve the mobile phase and diluting made each 1 ml contains about 0.5 mg of solution, as the test solution, precision quantity is adequate, and mobile phase quantitative dilution made each 1 ml contains 5 mu g solution, as the reference solution. According to content determination under the chromatographic conditions, take 20 mu l reference solution into the liquid chromatograph, adjust the detection sensitivity, the height of the chromatographic peak of main component is approximately 10% of full scale. More precise measuring each 20 mu l solution and reference solution, injection liquid chromatograph respectively, record chromatograph chart to 2 times of retention time of principal component peaks. In the chromatograph chart of test sample solution, if there is any impurity peak area of each impurity peak and shall not be greater than the main peak area of reference solution (1.0%).

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