Terbutaline Tablets
Action and use
Beta2-adrenoceptor agonist; bronchodilator.
Definition
Terbutaline Tablets contain Terbutaline Sulfate.
Content of terbutaline sulfate (C12H19NO3)2,H2SO4
90.0 to 110.0% of the stated amount.
Identification
5 volumes of formic acid, 25 volumes of cyclohexane and 65 volumes of propan-2-ol.
The spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2) and the principal spot in the chromatogram obtained with solution (3) appears as a single compact spot.
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
Prepare a 0.05m solution of ammonium formate by dissolving 3.15 g of ammonium formate in 980 mL of water, adjust the pH to 3.0 by the addition of about 8 mL of anhydrous formic acid and add sufficient water to produce 1000 mL. Dissolve 4.23 g of sodium hexanesulfonate in 770 mL of the ammonium formate solution and add 230 mL of methanol.
When the chromatograms are recorded under the prescribed conditions the retention times are about 9 minutes for terbutaline impurity C and about 11 minutes for terbutaline sulfate.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to terbutaline sulfate and terbutaline impurity C is at least 2.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to terbutaline impurity C is not greater than twice the area of the peak due to terbutaline impurity C in the chromatogram obtained with solution (3) (0.2%);
the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);
the sum of the areas of any such peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (0.4%).
Disregard any peaks with an area less than 0.1 times the area of the principal peak in the chromatogram obtained with solution (2) (0.02%) and any peaks with a retention time of less than 2.5 minutes.
Assay
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The chromatographic conditions described under Related substances may be used.
Calculate the content of (C12H19NO3)2,H2SO4 in the tablets from the chromatograms obtained and using the declared content of (C12H19NO3)2,H2SO4 in terbutaline sulfate BPCRS.