Dronedarone Tablets
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Dronedarone Tablets contain an amount of dronedarone hydrochloride equivalent to NLT 95.0% and NMT 105.0% of the labeled amount of dronedarone free base (C31H44N2O5S).
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 absorption spectra of the dronedarone peak in the Sample solution exhibit maxima and minima at the same wavelengths as those of the corresponding peak of the Standard solution, as obtained in the Assay.
3 ASSAY
PROCEDURE
Buffer: Combine 2.0 mL of triethylamine with 1 L of water and adjust with phosphoric acid to a pH of 3.0.
Mobile phase: Acetonitrile and Buffer (50:50)
System suitability stock solution: 0.2 mg/mL each of USP Dronedarone Hydrochloride RS and USP Dronedarone Related Compound A RS in methanol
System suitability solution: 0.01 mg/ml, each of USP Dronedarone Hydrochloride RS and USP Dronedarone Related Compound A RS in
Mobile phase from the System suitability stock solution
Standard stock solution: 2.13 mg/mL of USP Dronedarone Hydrochloride RS in methanol
Standard solution: 0.11 mg/mL of USP Dronedarone Hydrochloride RS in Mobile phase from the Standard stock solution
Sample stock solution: Nominally equivalent to 4 mg/mL of dronedarone in methanol prepared as follows. Dissolve and dilute in methanol to volume, an amount equivalent to 400 mg of dronedarone from NLT 20 finely powdered Tablets, taken in a 100-ml volumetric flask. Sonicate for about 5 min and allow to settle at room temperature.
Mobile p Sample solution: Nominally equivalent to 0.1 mg/ml of dronedarone in Mobile phase from the Sample stock solution. Pass through a suitable filter of 0.45-um pore size and discard the first 3 mL of the filtrate
Chromatographic system
(See Chromatography (621) System Suitability)
Mode: LC
Detectors
Assay: UV 288 nm
Identification test B: UV diode array
Column: 4.6 mm 25-cm; 5-um packing L10
Flow rate: 0.8 ml/min
Injection volume: 20 µL
Run time: NLT 2.15 times the retention time of dronedarone
System suitability
Sample: System suitability solution
[NOTE-The relative retention times for dronedarone related compound A and dronedarone are 0.7 and 1.0, respectively.]
Suitability requirements
Resolution: NLT 8 between dronedarone and dronedarone related compound A
Tailing factor: 0.8-2.1 for dronedarone
Relative standard deviation: NMT 1.5%, for dronedarone
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of dronedarone free base (CHNOS) in the portion of Tablets taken:
(rU/(rS) × (CS /CU) × (Mr1 /Mr2) × 100
rU = peak response of dronedarone from the Sample solution
rS = peak response of dronedarone from the Standard solution
CS = concentration of USP Dronedarone Hydrochloride RS in the Standard solutionn (mg/ml)
CU = nominal concentration of of dronedarone in the Sample sulation (mg/ml)
Mr1 = molecular weight of dronedarone free base, 556.76
Mr2 = molecular weight of dronedarone hydrochloride, 593.22
Acceptance criteria: 95.0%-105.0%
4 PERFORMANCE TESTS
Change to read:
DISSOLUTION (711)
Medium: 13.61 g/L of monobasic potassium phosphate in water. Adjust with 0.1 M hydrochloric acid or 0.1 M sodium hydroxide as needed to a pH of 4.5, 1000 mL
Apparatus 2: 75 rpm, with sinker ring
Times: 30 and 90 min
Standard solution: 0.43 mg/mL of USP Dronedarone Hydrochloride RS prepared as follows. Dissolve a suitable amount of USP Dronedarone
Hydrochloride RS in 2% of the total volume of methanol and dilute with Medium to volume
Sample solution: Pass a portion of sample under test through a suitable filter.
Instrumental conditions
Analytical wavelength: UV 288 nm
Cell: 1 mm
Blank: Medium
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of dronedarone dissolved
Result = (AU/AS) x CS x V x (1/L) x (Mr1/Mr2) x 100
AU = absorbance from the Sample solution
AS = absorbance from the Standard solution
CS = concentration of USP Dronedarone Hydrochloride BS in the Standard solution (mg/mL)
V = volume of Medium, 1000 mL
L = label claim (mg/Tablet)
Mr1 = molecular weight of dronedarone free base, 556.76
Mr2 = molecular weight of dronedarone hydrochloride, 593.22
Tolerances
30 min: 20.0%-60.0% of the labeled amount of dronedarone free base (C31H44N2O5S) is dissolved.
90 min: NLT 80% (Q) of the labeled amount of dronedarone free base (C31H44N2O5S) is dissolved.
UNIFORMITY OF DOSAGE UNITS (905): Meet the requirements
5 IMPURITIES
ORGANIC IMPURITIES
Buffer, Mobile phase, and System suitability stock solution: Proceed as directed in the Assay
System suitability solution: 0.01 mg/ml each of USP Dronedarone Hydrochloride RS and USP Dronedarone Related Compound A.RS prepared as follows. To a suitable amount of System suitability stock solution, add 20% of the total volume of methanol and dilute with Mobile phase to volume.
Standard stock solution: 0.4 mg/ml of USP Dronedarone Hydrochloride RS in methanol
Standard solution: 0.002 mg/ml. of USP Dronedarone Hydrochloride RS prepared as follows. To a suitable amount of Standard stock solution, add 25% of the total volume of methanol and dilute with Mobile phase to volume.
Sensitivity solution: 0.0005 mg/mL of USP Dronedarone Hydrochloride RS prepared as follows. To a suitable amount of the Standard solution, add 20% of the total volume of methanol and dilute with Mobile phase to volume.
Sample stock solution: Nominally equivalent to 4 mg/mL of dronedarone in methanol prepared as follows. Dissolve and dilute in methanol to volume, an amount equivalent to 400 mg of dronedarone from NLT 20 finely powdered Tablets, taken in a 100-ml volumetric flask. Sonicate for about 5 min and allow to settle at room temperature.
Sample solution: Nominally equivalent to 1 mg/mL of dronedarone in Mobile phase from Sample stock solution. Pass through a suitable filter of 0.45-um pore size and discard the first 3 ml. of the filtrate
Chromatographic system
(See Chromatography (521), System Suitability)
Mode: LC
Detector: UV 246 nm
Column: 4.6-mm x 25-cm; 5-µm packing L10
Flow rate: 0.8 mL/min
Injection volume: 20 µL
Run time: NLT 3.6 times the retention time of dronedarone
System suitability
Samples: System suitability solution and Sensitivity solution
[NOTE-The relative retention times for dronedarone related compound A and dronedarone are 0.7 and 1.0, respectively]
Suitability requirements
Resolution: NLT 8 between dronedarone and dronedarone related compound A, System suitability solution
Signal-to-noise ratio: NLT 10, Sensitivity solution
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of each impurity in the portion of Tablets taken:
(rU/(rS) × (CS /CU) x (Mr1/Mr2) x 100
rU = peak response of each impurity from the Sample solution
rS = peak response of dronedarone from the Standard solution
CS = concentration of USP Dronedarone Hydrochloride RS in the Standard solutionn (mg/ml)
CU = nominal concentration of of dronedarone in the Sample sulation (mg/ml)
Mr1 = molecular weight of dronedarone free base, 556.76
Mr2 = molecular weight of dronedarone hydrochloride, 593.22
Acceptance criteria: Disregard peaks less than 0.05%
Any unspecified impurity: NMT 0.20%
Total impurities: NMT 0.4%
6 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Store at controlled room temperature
