Ritodrine Tablets
Action and use
Beta2-adrenoceptor agonist; bronchodilator.
Definition
Ritodrine Tablets contain Ritodrine Hydrochloride.
Content of ritodrine hydrochloride, C17H21NO3,HCl
93.0 to 105.0% of the stated amount.
Identification
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
300 mL of methanol and 6.6 g of diammonium hydrogen orthophosphate and 1.1 g of sodium heptanesulfonate in 700 mL of water adjusted to pH 3.0 with an 85% v/v solution of orthophosphoric acid.
When chromatograms are recorded under the prescribed conditions, the relative retention times relative to ritodrine are: impurity A, about 0.3; impurity D, about 1.2; impurity E, about 2.3.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the two principal peaks (ritodrine and impurity D) is at least 1.5.
Identify any peaks due to impurity E in the chromatogram obtained with solution (1) and multiply the area of this peak by a correction factor of 0.2
In the chromatogram obtained with solution (1):
the area of any peak corresponding to impurities A, D and E is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1% of each).
The degradation products 4-hydroxybenzoic acid and 4-hydroxybenzaldehyde are formed in equimolar amounts with tyramine.
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.
300 mL of methanol and 6.6 g of diammonium hydrogen orthophosphate and 1.1 g of sodium heptanesulfonate in 700 mL of water adjusted to pH 3.0 with an 85% v/v solution of orthophosphoric acid.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the two principal peaks (ritodrine and impurity D) is at least 1.5.
Calculate the content of C17H21NO3,HCl in the tablets using the declared content of C17H21NO3,HCl in ritodrine hydrochloride BPCRS.
Storage
Ritodrine Tablets should be protected from light.
IMPURITIES
The impurities limited by the requirements of this monograph include those listed under Ritodrine Hydrochloride.