Cabergoline 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

Cabergoline Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of cabergoline (C₂₆H₃₇N₅O₂)

2 IDENTIFICATION

A. The retention time of the major peak of the Identification sample solution corresponds to that of the Identification standard solution, as obtained in the Assay.

B. The UV-Vis spectrum of the major peak of the Identification sample solution corresponds to that of the Identification standard solution, as obtained in the Assay.

3 ASSAY

PROCEDURE

Prepare solutions immediately before use, and protect from light..

Buffer: Transfer 6.8 g of monobasic potassium phosphate to a 1-L volumetric flask. Dissolve the contents in 900 mL of water. Adjust with phosphoric acid to a pH of 2.0. Dilute with water to volume, and add 0.2 mL of triethylamine.

Mobile phase: Acetonitrile and Buffer (16:84)

Standard solution: 0.25 mg/mL of USP Cabergoline RS in Mobile phase. Sonication may be used to aid in the dissolution of cabergoline.

Identification standard solution: 0.1 mg/mL of USP Cabergoline RS from the Standard solution in Mobile phase. [NOTE-This solution is used for Identification A and Identification B.]

Sample solution: Nominally 0.25 mg/mL of cabergoline from finely powdered Tablets in solution prepared as follows. Finely powder NLT 20 Tablets, and transfer a suitable portion of this fine powder to an appropriate volumetric flask. Dilute with Mobile phase to volume, and sonicate until completely dissolved. The resulting solution may be passed through a PVDF-type filter of 0.45-um pore size before analysis.

Identification sample solution: Nominally 0.1 mg/mL of cabergoline from the Sample solution in Mobile phase. [NOTE-This solution is used. for Identification A and Identification B.]

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 280 nm. For Identification B, use a diode array detector in the range of 210-400 nm.

Column: 4.0-mm x 25-cm; 10-um packing 11

Flow rate: 1.3 mL/min

Injection volume: 100 µL

System suitability

Sample: Standard solution

Suitability requirements

Column efficiency: NLT 1000 theoretical plates

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution, Identification standard solution, Sample solution, and Identification sample solution

Calculate the percentage of the labeled amount of cabergoline (C₂₆H₃₇N₅O₂) in the portion of Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

C_s = concentration of USP Cabergoline RS in the Standard solution (mg/mL)

C_u = nominal concentration of cabergoline in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: 0.1 N hydrochloric acid; 500 mL, degassed with helium

Apparatus 2: 50 rpm

Time: 15 min

Buffer, Mobile phase, and Chromatographic system: Proceed as directed in the Assay.

Standard solution: 0.001 mg/mL of USP Cabergoline RS in Medium

Sample solution: Pass a portion of the solution under test through a suitable lter, discarding the rst few mL.

System suitability

Sample: Standard solution

Suitability requirements

Column eciency: NLT 3000 theoretical plates

Relative standard deviation: NMT 2%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of cabergoline (C₂₆H₃₇N₅O₂) dissolved:

Result = (r_u /r_s ) × C_s × V × (1/L) × 100

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

C_s = concentration of USP Cabergoline RS in the Standard solution (mg/mL)

V = volume of Medium, 500 mL

L = label claim (mg/Tablet)

Tolerances: NLT 75% (Q) of the labeled amount of cabergoline (C₂₆H₃₇N₅O₂) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

ORGANIC IMPURITIES

Prepare solutions immediately before use, and protect from light.

System suitability solution: To 10 mL of 0.1 N sodium hydroxide, add 50 mg of cabergoline. Stir for 15 min. To 1 mL of the suspension, add 1 mL of 0.1 N hydrochloric acid, and dilute with Mobile phase to 10 mL Sonicate until dissolution is complete. The main degradation product obtained is cabergoline acid.

Injection volume

System suitability solution: 20 μι

Sample solution: 100 µL

System suitability

Sample: System suitability solution

Suitability requirements

Analysis

Sample: Sample solution

Calculate the percentage of each impurity in the portion of Tablets taken:

Result = (r_u /r_T ) × 100

r_u = peak response of each impurity from the Sample solution

r_T = sum of peak responses of all impurities and cabergoline from the Sample solution

Calculate the percentage of total impurities in the portion of Tablets taken:

Result = (r_u /r_T ) × 100

r_u = sum of peak responses of all impurities from the Sample solution

r_T = sum of peak responses of all impurities and cabergoline from the Sample solution

Table 1

^a (6aR,9R,10aR)-7-Allyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinoline-9-carboxylic acid.

^b (6aR,9R,10aR)-7-Allyl-N-(3-(dimethylazinoyl)propyl)-N-(ethylcarbamoyl)-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinoline-9- carboxamide.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in light-resistant, tight containers, and store at controlled room temperature.

USP Reference Standards 〈11〉

USP Cabergoline RS