Dissolution, Procedure for a Pooled Sample 711
water; 900 mL.
Determine the amount of (C12H19NO3)2·H2SO4 dissolved, employing the procedure set forth in the Assay, making any necessary modifications.
Not less than 75% (Q) of the labeled amount of (C12H19NO3)2·H2SO4 is dissolved in 45 minutes.
Ion-pair solution, Mobile phase, System suitability solution, and Chromatographic system
Proceed as directed in the Assay
under Terbutaline Sulfate.
Dissolve an accurately weighed quantity of USP Terbutaline Sulfate RS
in Mobile phase
, and dilute quantitatively, and stepwise if necessary, with Mobile phase
to obtain a solution having a known concentration of about 1 mg per mL. Transfer 10.0 mL of the solution so obtained to a 100-mL volumetric flask, add 10 mL of 0.05 N sulfuric acid, dilute with water to volume, and mix.
Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 10 mg of terbutaline sulfate, to a 100-mL volumetric flask. Add 10 mL of 0.05 N sulfuric acid and 20 mL of water, and shake for 15 minutes. Dilute with water to volume, mix, and filter.
Separately inject equal volumes (about 20 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 terbutaline sulfate [(C12
] in the portion of Tablets taken by the formula:
100C(rU / rS)
in which C
is the concentration, in mg per mL, of USP Terbutaline Sulfate RS
in the Standard preparation;
are the terbutaline peak responses obtained from the Assay preparation
and the Standard preparation,