Selegiline Hydrochloride Capsules

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 Capsules contain NLT 90.0% and NMT 110.0% of the labeled amount of selegiline hydrochloride (C₁₃H₁₇N. 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. 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. 

3 ASSAY 

Change to read: Procedure 

Buffer: 11.5 g/L of monobasic ammonium phosphate in water. Adjust with phosphoric acid to a pH of 3.1. Mobile phase: Acetonitrile and Buffer (20:80) 

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

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

Sample stock solution: Nominally, 1 mg/mL of selegiline hydrochloride from the contents of Capsules (NLT 20), prepared as follows. To the weighted portion of the sample in a suitable volumetric flask add Mobile phase to ll 80% of the nal flask volume. Sonicate for at least 10 min. Dilute with Mobile phase to volume, and centrifuge a portion of the solution for at least 10 min. 

Sample solution: Nominally, 0.1 mg/mL of selegiline hydrochloride, by diluting a portion of the supernatant from the Sample stock solution with Mobile phase. Pass a portion of the solution through a suitable filter of 0.45-µm pore size. 

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.  Column: 3.9-mm × 30-cm; 10-µm packing L1 

Flow rate: 1 mL/min 

Injection volume: 20 µL 

Run time: NLT  1.5 times the retention time of selegiline 

System suitability 

Samples: System suitability solution and Standard solution 

[Note—The relative retention times for methamphetamine and selegiline are 0.6 and 1.0, respectively.] 

Suitability requirements 

Resolution: NLT 3 between methamphetamine and selegiline,   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 selegiline hydrochloride (C₁₃H₁₇N. HCl) in the portion of Capsules taken: 

Result = (r_U /r_S ) × (C_S /C_U ) × 100 

r_U = peak response of selegiline from the Sample solution 

r_S = peak response of selegiline from the Standard solution  

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

C_U = 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 

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

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

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

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 = (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 Selegiline Hydrochloride RS in the Standard solution (mg/mL)  

V = volume of Medium, 500 mL 

L = label claim (mg/Capsule) 

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 

Buffer and Mobile phase: Prepare as directed in the Assay. 

Standard stock solution A: 0.2 mg/mL each of USP Selegiline Hydrochloride RS and USP Selegiline Related Compound D RS in Mobile phase Standard stock solution B: 0.2 mg/mL of USP Methamphetamine Hydrochloride RS in Mobile phase 

Standard solution: 0.002 mg/mL  each of USP Selegiline Hydrochloride RS and USP Selegiline Related Compound D RS, and 0.02 mg/mL  of USP Methamphetamine Hydrochloride RS in Mobile phase from Standard stock solution A and Standard stock solution B, respectively 

Sample solution: Nominally, 1 mg/mL of selegiline hydrochloride in Mobile phase from the contents of Capsules (NLT 20), prepared as follows. To the weighted portion of the sample in a suitable volumetric flask add Mobile phase to ll 60% of the nal flask volume. Sonicate for at least 10 min, and dilute with Mobile phase to volume. Pass a portion of the solution through a suitable filter of 0.45-µm pore size. Chromatographic system: Proceed as directed in the Assay except for the Run time. 

Run time: NLT  3 times the retention time of selegiline 

System suitability 

Sample: Standard solution 

[Note—See Table 1 for the relative retention times.] 

Suitability requirements 

Resolution: NLT 6.0 between methamphetamine and selegiline related compound D; NLT 3.2 between selegiline related compound D and selegiline 

Relative standard deviation: NMT 10.0% for selegiline related compound D and selegiline   ; NMT 5.0% for methamphetamine   

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of methamphetamine and selegiline related compound D in the portion of Capsules taken: 

Result = (r_U /r_S ) × (C_S /C_U ) × 100 

r_U = peak response of methamphetamine or selegiline related compound D from the Sample solution  

r_S = peak response of the corresponding Reference Standard from the Standard solution  

C_S = concentration of the corresponding Reference Standard in the Standard solution (mg/mL) 

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

Calculate the percentage of each degradation product  in the portion of Capsules taken: 

Result = (r_U /r_S ) × (C_S /C_U ) × 100 

r_U = peak response of each degradation product  from the Sample solution 

r_S = peak response of USP Selegiline Hydrochloride RS from the Standard solution  

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

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

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

Table 1 

a Benzeneethanamine, N,α-dimethyl-, (S)-. 

b Does not include methamphetamine. 

6 ADDITIONAL REQUIREMENTS 

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

USP Reference Standards 〈11〉 

USP Methamphetamine Hydrochloride RS 

USP Selegiline Hydrochloride RS 

USP Selegiline Related Compound D RS 

(R)-N-(1-Phenylpropan-2-yl)prop-2-yn-1-amine hydrochloride. 

C₁₂H₁₅N · HCl 209.72