Sotalol Hydrochloride Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Sotalol Hydrochloride Tablets contain NLT 95.0% and NMT 105.0% of the labeled amount of sotalol hydrochloride (C₁₂H₂₀N₂O₃S · HCl).

2 IDENTIFICATION

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

B. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

PROCEDURE

Mobile phase: 2 g/L of octanesulfonic acid sodium salt prepared as follows. Transfer a suitable quantity of octanesulfonic acid sodium salt to an appropriate container containing 79% of the container volume of water. Adjust with phosphoric acid to a pH of 3.0. Dilute with acetonitrile to volume.

System suitability solution: 0.2 mg/mL of USP Sotalol Hy drochloride RS and 0.6 µg/mL of USP Sotalol Related Compound A RS in Mobile phase. Sonicate to dissolve as needed.

Standard solution: 0.2 mg/mL of USP Sotalol Hy drochloride RS in Mobile phase. Sonicate to dissolve as needed.

Sample stock solution: Nominally 2 mg/mL of sotalol hydrochloride from Tablets in Mobile phase prepared as follows. Weigh Tablets (NLT 5) into a suitable volumetric flask. Add about 60% of the volume of Mobile phase. Sonicate for NLT 20 min to disintegrate the tablets. Then shake by mechanical means for NLT 20 min. Allow to cool to room temperature. Dilute with Mobile phase to volume. Centrifuge a portion of the resulting solution and use the supernatant.

Sample solution: Nominally 0.2 mg/mL of sotalol hydrochloride from Sample stock solution in Mobile phase

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 228 nm. For Identification B, use a diode array detector in the range of 190–400 nm.

Column: 4.6-mm × 25-cm; 5-µm packing L1

Flow rate: 1 mL/min Injection volume: 10 µL

Run time: NLT 2 times the retention time of sotalol

System suitability

Samples: System suitability solution and Standard solution [NOTE—See Table 1 for relative retention times.]

Suitability requirements

Resolution: NLT 4.0 between sotalol and sotalol related compound A, System suitability solution

Relative standard deviation: NMT 1.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of sotalol hydrochloride (C₁₂H₂₀N₂O₃S · HCl) in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of sotalol from the Sample solution

r_S = peak response of sotalol from the Standard solution

C_S = concentration of USP Sotalol Hydrochloride RS in the Standard solution (mg/mL)

C_U = nominal concentration of sotalol hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 95.0%–105.0%

4 PERFORMANCE TESTS

DISSOLUTION 〈711〉

Medium: Water; 900 mL

Apparatus 2: 50 rpm

Time: 30 min

Standard solution: (L/900) mg/mL of USP Sotalol Hydrochloride RS in Medium, where L is the label claim of sotalol hydrochloride in mg/Tablet

Sample solution: Pass a portion of the solution under test through a suitable filter.

Instrument conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.) Mode: UV

Analytical wavelength: 230 nm Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of sotalol hydrochloride (C H N O S · HCl) dissolved:

Result = (A_U/A_S) × C_S × V × (1/L) × 100

A_U = absorbance of the Sample solution

A_S = absorbance of the Standard solution

C_S = concentration of USP Sotalol Hy drochloride RS in the Standard solution (mg/mL)

V = volume of Medium, 900 mL

L = label claim of sotalol hydrochloride (mg/Tablet)

Tolerances: NLT 80% (Q) of the labeled amount of sotalol hydrochloride (C₁₂H₂₀N₂O₃S · HCl) is dissolved.

UNIFORMITY OF DOSAGE UNITS 〈905〉: Meet the requirements

5 IMPURITIES

ORGANIC IMPURITIES

Mobile phase: Prepare as directed in the Assay.

Sensitivity solution: 2 µg/mL of USP Sotalol Hy drochloride RS in Mobile phase. Sonicate to dissolve as needed.

Standard solution: 6 µg/mL each of USP Sotalol Hydrochloride RS, USP Sotalol Related Compound A RS, USP Sotalol Related Compound B RS, and USP Sotalol Related Compound C RS in Mobile phase. Sonicate to dissolve as needed.

Sample solution: Nominally 2 mg/mL of sotalol hydrochloride from Tablets in Mobile phase prepared as follows. Weigh Tablets (NLT 5) into a suitable volumetric flask. Add about 60% of the volume of Mobile phase. Sonicate for NLT 20 min to disintegrate the tablets. Then shake by mechanical means for NLT 20 min. Allow to cool to room temperature. Dilute with Mobile phase to volume. Centrifuge a portion of the resulting solution and use the supernatant.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 228 nm

Column: 4.6-mm × 25-cm; 5-µm packing L1

Flow rate: 1 mL/min

Injection volume: 10 µL

Run time: NLT 2.5 times the retention time of sotalol

System suitability

Samples: Sensitivity solution and Standard solution [NOTE—See Table 1 for relative retention times.]

Suitability requirements

Resolution: NLT 4.0 between sotalol and sotalol related compound A, Standard solution

Relative standard deviation: NMT 5.0% each for sotalol, sotalol related compound A, sotalol related compound B, and sotalol related compound C, Standard solution

Signal-to-noise ratio: NLT 10, Sensitivity solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of sotalol related compound A, sotalol related compound B, or sotalol related compound C in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of sotalol related compound A, sotalol related compound B, or sotalol related compound C from the Sample solution

r_S = peak response of sotalol related compound A, sotalol related compound B, or sotalol related compound C from the Standard solution

C_S = concentration of USP Sotalol Related Compound A RS, USP Sotalol Related Compound B RS, or USP Sotalol Related Compound C RS in the Standard solution (mg/mL)

C_U = nominal concentration of sotalol hydrochloride in the Sample solution (mg/mL)

Calculate the percentage of any unspecified degradation product in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of any unspecified degradation product from the Sample solution

r_S = peak response of sotalol from the Standard solution

C_S = concentration of USP Sotalol Hy drochloride RS in the Standard solution (mg/mL)

C_U = nominal concentration of sotalol hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: See Table 1. The reporting threshold is 0.1%.

Table 1

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in well-closed containers, and store at controlled room temperature.

Change to read:

USP REFERENCE STANDARDS 〈11〉

USP Sotalol Hydrochloride RS

USP Sotalol Related Compound A RS

N-[4-(Isopropylglycyl)phenyl]methanesulfonamide hydrochloride. C₁₂H₁₈N₂O₃S · HCl    306.81

USP Sotalol Related Compound B RS

N-(4-Formylphenyl)methanesulfonamide. C₈H₉NO₃S    199.22

USP Sotalol Related Compound C RS

N-{4-[2-(Isopropylamino)ethyl]phenyl}methanesulfonamide hydrochloride. C₁₂H₂₀N₂O₂S · HCl    292.82 (CN 1-Aug-2024)