Sotalol Tablets

General Notices

Action and use

Beta-adrenoceptor antagonist; class II and class III antiarrhythmic.

Definition

Sotalol Tablets contain Sotalol Hydrochloride.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of sotalol hydrochloride, C12H20N2O3S,HCl

95.0 to 105.0% of the stated amount.

Identification

A. The light absorption, Appendix II B, in the range 230 to 350 nm, of the final solution obtained in the Assay exhibits a maximum only at 249 nm.
B. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
(1) Shake a quantity of the powdered tablets containing 50 mg of Sotalol Hydrochloride with 25 mL of methanol for 15 minutes, centrifuge and use the supernatant liquid.
(2) 0.2% w/v of sotalol hydrochloride BPCRS in water.
chromatographic conditions
(a) Use as the coating silica gel GF254.
(b) Use the mobile phase as described below in a tank saturated with ammonia vapour.
(c) Apply 2 µL of each solution.
(d) Develop the plate to 10 cm.
(e) After removal of the plate, dry it in a current of air for at least 5 minutes and examine under ultraviolet light (254 nm).
mobile phase

30 volumes of methanol and 70 volumes of chloroform.

confirmation

The principal spot in the chromatogram obtained with solution (1) corresponds in position, size and intensity to that in the chromatogram obtained with solution (2).

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1) Shake a quantity of the powdered tablets containing 50 mg of Sotalol Hydrochloride with 25 mL of the mobile phase for 15 minutes, centrifuge and use the supernatant liquid.
(2) Dilute 1 volume of solution (1) to 100 volumes with the mobile phase. Dilute 3 volumes of this solution to 10 volumes with the mobile phase.
(3) 0.0008% w/v of 4′-(2-isopropylaminoethyl)methanesulfonanilide hydrochloride BPCRS in the mobile phase.
chromatographic conditions
(a) Use a stainless steel column (20 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (10 µm) (Spherisorb ODS 2 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1.5 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 228 nm.
(f) Inject 20 µL of each solution.
mobile phase

210 volumes of acetonitrile and 790 volumes of a 0.2% w/v solution of sodium octanesulfonate, adjusted to pH 3.0 with orthophosphoric acid.

limits

In the chromatogram obtained with solution (1):

the area of any peak corresponding to 4′-(2-isopropylaminoethyl)methanesulfonanilide is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.4%);

the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);

the sum of the areas of any secondary peaks is not more than 1.65 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).

Assay

Weigh and powder 20 tablets. Shake a quantity of the powdered tablets containing 50 mg of Sotalol Hydrochloride with 175 mL of water for 15 minutes, add sufficient water to produce 250 mL and centrifuge. To 10 mL of the supernatant liquid add 20 mL of 1m sodium hydroxide and sufficient water to produce 200 mL. Measure the absorbance of the resulting solution at the maximum at 249 nm, Appendix II B, using 0.1m sodium hydroxide in the reference cell. Calculate the content of C12H20N2O3S,HCl taking 480 as the value of A(1%, 1 cm) at the maximum at 249 nm.

Storage

Sotalol Tablets should be protected from light.