硫酸沙丁胺醇美国药典检测方法？Assay— 0.05 ± 0.01 M Ammonium acetate solution— Dissolve 3.85 g of ammonium acetate in 1000 mL of water, and mix. Mobile phase— Prepare a degassed mixture of water, 0.05 ± 0.01 M Ammonium acetate solution, and isopropanol , and adjust dropwise with acetic acid to a pH of 4.5 ± 0.3. Resolution solution— Dissolve accurately weighed quantities of USP Albuterol Sulfate RS and USP Albuterol Related Compound A RS in water, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of about 0.140 mg per mL and 0.030 mg per mL, respectively. Standard preparation— Dissolve an accurately weighed quantity of USP Albuterol Sulfate RS in water, and dilute quantitatively with water to obtain a solution having a known concentration of about 0.6 mg per mL. Assay preparation— Transfer about 60 mg of Albuterol Sulfate, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with water to volume, and mix. Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 276-nm detector and a 4.6-mm × 20-cm column that contains packing L10. The flow rate is about 2.0 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the resolution, R, between albuterol and albuterol related compound A is not less than 1.5; and the relative standard deviation for replicate injections is not more than 1.5%. Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of (C13H21NO3)2·H2SO4 in the portion of Albuterol Sulfate taken by the formula: 100C(rU / rS) in which C is the concentration, in mg per mL, of USP Albuterol Sulfate RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.查看更多
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