Nadolol 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

Nadolol Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of nadolol (C₁₇H₂₇NO₄).

2 IDENTIFICATION

2.1 A. Thin-Layer Chromatographic Identification Test 〈201〉

Standard solution: 5 mg/mL of USP Nadolol RS in 0.1 N hydrochloric acid

Sample solution: Nominally 5 mg/mL of nadolol from powdered Tablets in 0.1 N hydrochloric acid. Stir for 30 min, using a magnetic stirrer, and place in an ultrasonic bath for an additional 30 min. Centrifuge, and use the supernatant.

Chromatographic system

Adsorbent: 0.25-mm layer of chromatographic silica gel mixture

Application volume: 100 µL

Developing solvent system: Acetone, chloroform, and 2 N ammonium hydroxide (80:10:10)

Analysis

Samples: Standard solution and Sample solution

Apply the Samples as streaks. Develop the chromatogram until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, allow the solvent to evaporate, and examine the chromatogram under short-wavelength UV light.

Acceptance criteria: The R_F value of the principal spot of the Sample solution corresponds to that of the Standard solution.

3 ASSAY

3.1 Procedure

Mobile phase: A mixture of 700 mL of methanol and 1300 mL of water containing 5.84 g of sodium chloride and 1.0 mL of 0.1 N hydrochloric acid

Standard solution: 0.2 mg/mL of USP Nadolol RS in Mobile phase

Sample solution: Equivalent to 0.2 mg/mL of nadolol from NLT 20 finely powdered Tablets in Mobile phase, prepared as follows. To a suitable amount of the powder in a suitable volumetric flask, add Mobile phase to fill 75% of the total volume. Place the flask in an ultrasonic bath for 15 min, shaking intermittently, and clarify the solution by filtration or centrifugation. Dilute with Mobile phase to volume.

Chromatographic system

• (See Chromatography 〈621〉, System Suitability.)
• Mode: LC
• Detector: UV 220 nm
• Column: 4.6-mm × 25-cm; packing L16
• Flow rate: 1 mL/min
• Injection volume: 20 µL

System suitability

• Sample: Standard solution
• Suitability requirements
• Tailing factor: NMT 3
• Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of nadolol (C₁₇H₂₇NO₄) in the portion of Tablets taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response of nadolol from the Sample solution

rₛ = peak response of nadolol from the Standard solution

Cₛ = concentration of USP Nadolol RS in the Standard solution (mg/mL)

Cᵤ = nominal concentration of nadolol in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

4.1 Dissolution 〈711〉

Medium: 0.01 N hydrochloric acid; 900 mL

Apparatus 1: 100 rpm

Time: 50 min

Solution A: Dissolve 5.84 g of sodium chloride in 1440 mL of water.

Mobile phase: Methanol and Solution A (560:1440). Adjust with 0.1 N hydrochloric acid to a pH of 2.5.

Standard solution: USP Nadolol RS in Medium

Sample solution: Use filtered portions of the solution under test. Dilute with Medium, as necessary.

Chromatographic system and System suitability: Proceed as directed in the Assay.

Analysis

Determine the percentage of the labeled amount of nadolol (C₁₇H₂₇NO₄) dissolved:

Result = (rᵤ/rₛ) × (Cₛ/L) × V × D × 100

rᵤ = peak response of nadolol from the Sample solution

rₛ = peak response of nadolol from the Standard solution

Cₛ = concentration of USP Nadolol RS in the Standard solution (mg/mL)

L = label claim (mg/tablet)

V = volume of Medium, 900 mL

D = dilution factor used in preparation of the Sample solution

Acceptance criteria: NLT 80% (Q) of the labeled amount of nadolol (C₁₇H₂₇NO₄) is dissolved.

4.2 Uniformity of Dosage Units 〈905〉

Meet the requirements

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Nadolol RS