Betamethasone Sodium Phosphate Tablets
Action and use
Glucocorticoid.
Definition
Betamethasone Sodium Phosphate Tablets contain Betamethasone Sodium Phosphate.
Content of betamethasone, C22H29FO5
90.0 to 110.0% of the stated amount.
Identification
20 volumes of acetic anhydride, 20 volumes of water and 60 volumes of butan-1-ol prepared immediately before use.
The test is not valid unless the chromatogram obtained with solution (4) shows two principal spots with almost identical Rf values.
The chromatograms obtained with solutions (1), (2) and (3) show single spots with identical Rf values.
Tests
Disintegration
Maximum time, 5 minutes, Appendix XII A1.
Uniformity of content
Tablets containing less than the equivalent of 2 mg and/or less than 2% w/w of betamethasone comply with the requirements stated under Tablets using the following method of analysis. Carry out the procedure protected from light. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
45 volumes of methanol and 55 volumes of citro-phosphate buffer pH 5.0.
Calculate the content of C22H29FO5 in each tablet, determining the exact strength of the solution of betamethasone sodium phosphate BPCRS as described in the Assay.
Assay
Weigh and powder 20 tablets. Carry out the procedure protected from light. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The chromatographic procedure described under Uniformity of content may be used.
Calculate the content of C22H29FO5 in the tablets, determining the exact strength of C22H29FO5 in solution (2) as follows. Dilute 5 mL of solution A to 25 mL with water and measure the absorbance, Appendix II B, of the resulting solution at the maximum at 241 nm, taking 391 as the value of A(1%, 1 cm) for betamethasone.
Storage
Betamethasone Sodium Phosphate Tablets should be protected from light.
Labelling
The quantity of active ingredient is stated in terms of the equivalent amount of betamethasone.