Sertraline Hydrochloride Oral Solution

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 

Sertraline Hydrochloride Oral Solution contains an amount of sertraline hydrochloride equivalent to NLT 90.0% and NMT 110.0% of the labeled amount of sertraline (C₁₇H₁₇Cl₂N). 

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. 

3 ASSAY 

Procedure 

Buffer: 0.8 g/L of ammonium acetate in water. To each L of this solution add 10 mL of triethylamine, and adjust with phosphoric acid to a pH of 5.0. 

Mobile phase: Acetonitrile and Buffer (30:70) 

Diluent: Methanol and water (50:50) 

Standard solution: 0.1 mg/mL of USP Sertraline Hydrochloride RS in Diluent 

Sample solution: Nominally, 0.1 mg/mL of sertraline in Diluent, from a portion of Oral Solution 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 220 nm 

Column: 4.6-mm × 15-cm; 5-µm packing L1 

Column temperature: 50° 

Flow rate: 2 mL/min 

Injection volume: 20 µL 

Run time: 1.3 times the retention time of sertraline 

System suitability 

Sample: Standard solution 

Suitability requirements 

Tailing factor: NMT 1.7 

Relative standard deviation: NMT 2.0% 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of the labeled amount of sertraline (C₁₇H₁₇Cl₂N) in the portion of Oral Solution taken: 

Result = (r_U/r_S) × (C_S/C_U) × (M_r1 /M_r2) × 100 

r_U = peak response of sertraline from the Sample solution 

r_S = peak response of sertraline from the Standard solution  

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

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

M_r1 = molecular weight of sertraline free base, 306.23  

M_r2 = molecular weight of sertraline hydrochloride, 342.69

Acceptance criteria: 90.0%–110.0% 

4 PERFORMANCE TESTS 

Deliverable Volume 〈698〉: Meets the requirement 

5 IMPURITIES 

Organic Impurities 

Buffer: Dissolve 5.7 g of β-cyclodextrin hydrate and 8 mL of triethylamine in 1 L of water. Adjust with phosphoric acid to a pH of 6.5 ± 0.1. Solvent mixture: Acetonitrile and methanol (55:45) 

Mobile phase: Solvent mixture and Buffer (40:60) 

Diluent: Acetonitrile and water (70:30) 

Standard solution: 2.3 µg/mL of USP Sertraline Hydrochloride RS in Diluent 

Sample solution: Nominally, 2 mg/mL of sertraline in Diluent, from a portion of Oral Solution 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 220 nm 

Column: 4.6-mm × 25-cm; 5-µm packing L11 

Column temperature: 40° 

Flow rate: 1.5 mL/min 

Injection volume: 20 µL 

Run time: 3 times the retention time of sertraline 

System suitability 

Sample: Standard solution 

Suitability requirements 

Tailing factor: NMT 2.0 

Relative standard deviation: NMT 5.0% 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of any individual degradation product in the portion of Oral Solution taken: 

Result = (r_U/r_S) × (C_S/C_U) × (M_r1 /M_r2) × 100 

r_U = peak response of each individual impurity from the Sample solution 

r_S = peak response of sertraline from the Standard solution  

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

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

M_r1 = molecular weight of sertraline free base, 306.23  

M_r2 = molecular weight of sertraline hydrochloride, 342.69 

Acceptance criteria: See Table 1. 

Table 1 

6 SPECIFIC TESTS 

pH 〈791〉: 4.5–6.0 

Microbial Enumeration Tests 〈61〉andTests for Specified Microorganisms 〈62〉: The total aerobic microbial count does not exceed 102 cfu/mL. The total molds and yeasts count does not exceed 101 cfu/mL. It meets the requirement of the test for absence of Escherichia coli. 

7 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in light-resistant containers. Store at controlled room temperature. 

USP Reference Standards 〈11〉 

USP Sertraline Hydrochloride RS