Escitalopram 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

Escitalopram Tablets contain an amount of Escitalopram Oxalate equivalent to NLT 90.0% and NMT 110.0% of the labeled amount of escitalopram (C₂₀H₂₁FN₂O).

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.

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: 1.5 g of anhydrous sodium acetate and 0.4 ml of glacial acetic acid in 1 L of water. Adjust with 1 N sodium hydroxide 2029; to a pH of 5.2. ▲FERR 1-May

Mobile phase: Methanol, acetonitrile, and Buffer (33:7:60)

System suitability solution: 6.4 µg/mL of USP Escitalopram Oxalate RS (equivalent to 5 µg/mL of escitalopran) and 1 µg/mL of USP Citalopram Related Comoound CBS in Mobile phase

Standard solution: 510 µg/mL of USP Escitalopram Oxalate RS (equivalent to 400 µg/ml of escitalopram) in Mobile phase

Sample solution: Nominally 400 µg/mL of escitalopram from Tablets prepared as follows. Transfer NLT 10 Tablets to a suitable volumetric flask, add Buffer to 10% of the total volume, and shake vigorously for 10 min. Add methanol to 50% of the total volume, shake for 1 additional min, sonicate for 10 min, and dilute with Mobile phase to volume.

Chromatographic system

(See Chromatogranby (621). System Suitability)

Mode: LC

Detector: UV 239 nm. For Identification B, use a diode array detector in the range of 210-400 nm.

Column: 4.6-mm × 10-cm; 3-μm packing L1

Column temperature: 45

Flow rate: 1 mL/min

Injection volume: 10 µL

Run time: NLT 3 times the retention time of escitalopram

System suitability

Samples: System suitability solution and Standard solution

[Nort-See Table 1 for the relative retention times]

Suitability requirements

Resolution: NLT 3.0 between escitalopram and citalopram related compound C, 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 escitalopram (C₂₀H₂₁FN₂O) in the portion of Tablets taken:

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

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Escitalopram Oxalate RS in the Standard solution (µg/mL)

C_U = nominal concentration of escitalopram in the Sample solution (ug/ml)

M_r1 = molecular weight of escitalopram, 324.39

M_r2 = molecular weight of escitalopram oxalate, 414.43

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

Change to read:

DISSOLUTION (711)

Test 1

[NOTE-USP Citalopram Hydrobromide RS is used as a quantitative standard with an appropriate molecular weight correction. Escitalopram

is an optical isomer of citalopram.]

Medium: 01 N hydrochloric acid: 900 mL

Apparatus 2: 50 rpm

Time: 30 min

Standard solution 1: 3 µg/mL of USP Citalopram Hydrobromide RS (equivalent to 2.4 µg/mL of citalopram) in Medium

Standard solution 2: 15 µg/mL of USP Citalopram Hydrobromide RS (equivalent to 12 µg/mL of citalopram) in Medium

Standard solution 3: 30 µg/mL of USP Citalopram Hydrobromide RS (equivalent to 24 µg/mL of citalopram) in Medium

Sample solution: Pass a portion of the solution under test through a suitable filter of 0.45-um pore size.

Instrumental conditions

(See Liftraviolet-Visible Spectroscopy (857).)

Mode: UV-Vis

Analytical wavelength: 239 nm

Cell: 0.5 cm

Blank: Medium

System suitability

Samples: Standard solution 1, Standard solution 2, and Standard solution 3

Suitability requirements

Correlation coefficient: NLT 0.995, determined using Standard solution 1. Standard solution 2, and Standard solution 3, three replicates of each solution

Relative standard deviation: NMT 2.0%, determined using Standard solution 3, six replicates

Analysis

Samples: Standard solution 1, Standard solution 2, Standard solution 3, and Sample solution

Calculate the concentration, in µg/mL, of citalopram for each Standard solution (i):

Result_i = C_Si x (M_r1/M_r2)

C_Si = concentration of USP Citalopram Hydrobromide RS in the Standard solution (1) (µg/mL)

M_r1 = molecular weight of citalopram, 324.39

M_r2 = molecular weight of citalopram hydrobromide, 405.30

Plot the absorbances of Standard solution 1, Standard solution 2, and Standard solution 3 versus the corresponding citalopram concentrations

Determine the concentration, C, in µg/ml, of escitalopram in the Sample solution using the calibration curve.

Calculate the percentage of the labeled amount of escitalopram (C₂₀H₂₁FN₂O) dissolved:

Result = C_u x V x (1/L) x F x100

C_u = nominal concentration of escitalopram in the Sample solution (µg/mL)

V = volume of Medium, 900 ml

L = label claim (mg/Tablet)

F = conversion factor, 0.001 mg/µg

Tolerances: NLT 80% (Q) of the labeled amount of escitalopram (C₂₀H₂₁FN₂O) is dissolved.

Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.

Medium: 0.1 N bydrochloric acid (ERR 1-May-2023): 900 ml.

Apparatus 2: 75 rpm

Time: 30 min

Buffer: 3.4 g/L of monobasic notassium phosphate in water. To each 1 L of the mixture, add 1.0 ml of triethylamine, and adjust with 1.5 M

phosphoric acid TS to a pH of 3.8.

Mobile phase: Acetonitrille, methanol, and Buffer (28:5:57)

Standard solution: (1/900) mg/ml, of escitalopram from USF Exotalcoram Oxalate RS in Medlom, where the label claim of ecitalopram

Sample solution: Pass a portion of the solution through a suitable fiter of 45 um pore size

Chromatographic system

(See Chromatogrgone 16211 System Stutihily)

Mode: LC

Detector: LV 238 nm

Column 4.6mm x 15 cm, 9-um packing L1

Flow rate: 1.5 mL/min

Injection volume: 20 μL

System suitability

Sample: Standard audition

Suitability requirements

Talling factor: NMT 2.0

Relative standard deviation NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of escitalopram (C₂₀H₂₁FN₂O) dissolved:

Result = (r_U/(r_S) × C_S x (M_r1/M_r2) x V x (1/L) x 100

r_U = peak response of escitalopram from the Sample solution

r_S = peak response of escitalopram from the Standard solution

C_S = concentration of USP Escitalocram Oxalate RS in the Standard solution (mg/ml)

M_r1 = molecular weight of escitalopram 324.39

M_r2 = molecular weight of escitalopram oxalate, 414.43

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

Tolerances: NLT 801% (Q) of the labeled amount of escitalopram is dissolved

Uniformity of Dosage Units (905): Meet the requirements

5 IMPURITIES

Buffer, Mobile phase, System suitability solution, Sample solution, and Chromatographic system: Proceed as directed in the Assay Standard solution: 1.0 µg/mL of USP Escitalopram Oxalate RS (equivalent to 0.8 μg/mL of escitalopram) in Mobile phase

System sultability

Samples: Spotem sumability solution and Standard solution

[Note-See Table 1 for the relative retention times]

Suitability requirements

Resolution: NLT 3.0 between escitalopram and citalopram selated compound C. System suitability solution

Relative standard deviation: NMT 50%, Standard solution

Analysis

Samples: Sample solution and Standard solution

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

Result = (r_U/(r_S) × (C_S /C_U) x (1/F)  x (M_r1/M_r2) × 100

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

r_S = peak response of escitalopram from the Standard solution

C_S = concentration of USP Escitalopram Oxalate RS in the Standard solution (μg/mL)

C_U = nominal concentration of escitalopram in the Sample solution (μg/mL)

F = relative responce factor (see Table 1)

M_r1 = molecular weight of escitalopram, 324.39

M_r2 = molecular weight of escitalopram zalate 414.43

Acceptance criteria: See Table 1

a 1-(3-Dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carboxamide.

b 1-(3-Dimethylaminopropyl)-1-(4-fluorophenyl)-3-hydroxy-1,3-dihydroisobenzofuran-5-carbonitrile.

c 1-(3-Dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile-N-oxide.

ADDITIONAL REQUIREMENTS

Labeling: The labeling states the Dissolution test used only if Test 1 is not used.
Packaging and Storage: Preserve in well-closed containers. Store at controlled room temperature.