Selegiline 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

Selegiline Hydrochloride Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of selegiline hydrochloride (C₁₃H₁₇N · HCl).

2 IDENTIFICATION

Change to read:

▲A.▲ (USP 1-Aug-2020) The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

Add the following:

▲• B. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.▲ (USP 1-Aug-2020)

3 ASSAY

Change to read:

Procedure

Solution A: 0.1 M monobasic ammonium phosphate. Adjust with phosphoric acid to a pH of 3.1.

Mobile phase: Acetonitrile and Solution A (20:80)

System suitability solution: 0.1 mg/mL each of USP Methamphetamine Hydrochloride RS and USP Selegiline Hydrochloride RS in Mobile phase

Standard solution: 0.1 mg/mL of USP Selegiline Hydrochloride RS in Mobile phase

▲Sample stock solution:▲ (USP 1-Aug-2020) Nominally 1 mg/mL of selegiline hydrochloride from Tablets prepared as follows. Finely powder NLT 20 Tablets and transfer a suitable portion of the powder to a suitable volumetric flask. Add 80% of the flask volume of Mobile phase, sonicate for 10 min, dilute with Mobile phase to volume. Centrifuge a portion of this solution for 10 min and use the supernatant. [Note—The use of a centrifuge speed of NLT 3500 rpm may be suitable.]

Sample solution: Nominally 0.1 mg/mL of selegiline hydrochloride from Sample stock solution diluted with Mobile phase

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 205 nm. ▲For Identification B, use a diode array detector in the range of 190–400 nm.▲ (USP 1-Aug-2020)

Column: 3.9-mm × 30-cm; ▲10-µm▲ (USP 1-Aug-2020) packing L1

Flow rate: 1 mL/min

Injection volume: 20 µL

▲Run time: NLT 2.5 times the retention time of selegiline▲ (USP 1-Aug-2020)

System suitability

Sample: System suitability solution

Suitability requirements

Resolution: NLT ▲3.0▲ (USP 1-Aug-2020) between methamphetamine and selegiline

Relative standard deviation: ▲NMT 1.0%▲ (USP 1-Aug-2020)

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of selegiline hydrochloride (C₁₃H₁₇N · HCl) in the portion of Tablets taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response from the Sample solution

rₛ = peak response from the Standard solution

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

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

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: Water; 500 mL

Apparatus 1: 50 rpm

Time: 20 min

Solution A and Mobile phase: Prepare as directed in the Assay.

Standard solution: 0.01 mg/mL of USP Selegiline Hydrochloride RS in water

Sample solution: Withdraw a 10-mL portion of the solution under test, and centrifuge. [Note—A centrifugation speed of 3500 rpm for 10 min is recommended.]

Chromatographic system: Proceed as directed in the Assay except for the Injection volume.

Injection volume: 15 µL

System suitability

Sample: Standard solution

Suitability requirements

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of selegiline hydrochloride (C₁₃H₁₇N · HCl) dissolved:

Result = (rᵤ/rₛ) × Cₛ × V × (1/L) × 100

rᵤ = peak response from the Sample solution

rₛ = peak response from the Standard solution

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

V = volume of Medium = 500 mL

L = label claim (mg/Tablet)

Tolerances: NLT 80% (Q) of the labeled amount of selegiline hydrochloride (C₁₃H₁₇N · HCl) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

Change to read:

Organic Impurities, Procedure 1

Solution A, Mobile phase, System suitability solution, and Chromatographic system: Proceed as directed in the Assay.

Standard solution: 0.005 mg/mL each of USP Methamphetamine Hydrochloride RS and USP Selegiline Hydrochloride RS from the System suitability solution diluted with Mobile phase

▲Sample solution: Nominally 1 mg/mL of selegiline hydrochloride from Tablets prepared as follows. Finely powder NLT 20 Tablets and transfer a suitable portion of the powder to a suitable volumetric flask. Add 80% of the flask volume of Mobile phase, sonicate for 10 min, and dilute with Mobile phase to volume. Centrifuge a portion of this solution for 10 min and use the supernatant. [Note—The use of a centrifuge speed of NLT 3500 rpm may be suitable.]▲ (USP 1-Aug-2020)

System suitability

Sample: Standard solution

Suitability requirements

Resolution: NLT ▲3.0▲ (USP 1-Aug-2020) between methamphetamine and selegiline

Relative standard deviation: NMT 5.0% for selegiline

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each impurity, excluding methamphetamine hydrochloride:

Result = (rᵢ/rₛ) × (Cₛ/Cᵤ) × 100

rᵢ = peak response of each impurity from the Sample solution

rₛ = peak response of selegiline from the Standard solution

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

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

Acceptance criteria

Individual impurities: NMT 0.5%

Total impurities: NMT 2.0% (excluding methamphetamine hydrochloride)

Change to read:

Organic Impurities, Procedure 2: Limit of Methamphetamine Hydrochloride

Solution A, Mobile phase, System suitability solution, and Chromatographic system: Proceed as directed in the Assay.

Standard solution: ▲0.02 mg/mL each of▲ (USP 1-Aug-2020) USP Methamphetamine Hydrochloride RS and ▲USP Selegiline Hydrochloride RS▲ from the System suitability solution diluted with Mobile phase

▲Sample solution: Nominally 1 mg/mL of selegiline hydrochloride from Tablets prepared as follows. Finely powder NLT 20 Tablets and transfer a portion of the powder equivalent to 50 mg of selegiline hydrochloride to a suitable volumetric flask. Add 80% of the flask volume of Mobile phase, sonicate for 10 min, and dilute with Mobile phase to volume. Centrifuge a portion of this solution for 10 min and use the supernatant. [Note—The use of a centrifuge speed of NLT 3500 rpm may be suitable.]▲ (USP 1-Aug-2020)

System suitability

Sample: Standard solution

Suitability requirements

Resolution: NLT ▲3.0▲ (USP 1-Aug-2020) between methamphetamine and selegiline

Relative standard deviation: NMT 5.0% for selegiline and methamphetamine

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of methamphetamine hydrochloride in the portion of Tablets taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response of methamphetamine from the Sample solution

rₛ = peak response of methamphetamine from the Standard solution

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

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

Acceptance criteria: NMT 2.0% for methamphetamine hydrochloride

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers.

USP Reference Standards 〈11〉

USP Methamphetamine Hydrochloride RS

USP Selegiline Hydrochloride RS