Cetirizine 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 

Cetirizine Hydrochloride Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of cetirizine hydrochloride (C₂₁H₂₅ClN₂O₃.2HCl).

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 

Solution A: 2 N sulfuric acid and water (2:33) 

Buffer: 2.9 mL/L of phosphoric acid in water 

Mobile phase: Acetonitrile and Buffer (3:7) 

Diluent: Acetonitrile, Solution A, and water (100:1:100) 

Standard solution: 0.2 mg/mL of USP Cetirizine Hydrochloride RS in Diluent 

Sample solution: 0.2 mg/mL of cetirizine hydrochloride in Diluent from NLT 20 powdered Tablets. [Note—Sonicate, if necessary.] 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 230 nm 

Column: 4.6-mm × 25-cm; 5-µm packing L1 

Flow rate: 1.5 mL/min 

Injection volume: 10 µL 

Run time: 1.3 times the retention time of cetirizine 

System suitability 

Sample: Standard solution 

Suitability requirements 

Tailing 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 cetirizine hydrochloride (C₂₁H₂₅ClN₂O₃.2HCl) in the portion of Tablets taken: 

Result = (r_U/r_S) × (C_S/C_U) × 100 

r_U = peak response from the Sample solution 

r_S = peak response from the Standard solution 

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

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

Acceptance criteria: 90.0%–110.0% 

4 PERFORMANCE TESTS 

Dissolution 〈711〉 

Test 1 

Medium: Water; 900 mL, degassed 

Apparatus 2: 50 rpm 

Time: 30 min 

Buffer: 2.9 mL/L of phosphoric acid in water 

Mobile phase: Acetonitrile and Buffer (2:3) 

Standard solution: 11 µg/mL of USP Cetirizine Hydrochloride RS in water. This solution can be stored for 48 h at room temperature. Sample solution: Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 230 nm 

Column: 4.6-mm × 25-cm; 5-µm packing L1 

Flow rate: 1 mL/min 

Injection volume: 50 µL 

Run time: 1.3 times the retention time of cetirizine 

System suitability 

Sample: Standard solution 

Suitability requirements 

Tailing 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 cetirizine hydrochloride (C₂₁H₂₅ClN₂O₃.2HCl) dissolved: 

Result = (r_U/r_S) × (C_S /L) × V × 100 

r_U = peak response from the Sample solution 

r_S = peak response from the Standard solution 

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

L = label claim (mg/Tablet) 

V = volume of Medium, 900 mL 

Tolerances: NLT 80% (Q) of the labeled amount of cetirizine hydrochloride (C₂₁H₂₅ClN₂O₃.2HCl) is dissolved. 

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

Medium: Water; 900 mL 

Apparatus 2: 75 rpm 

Time: 30 min 

Buffer: 0.4 g/L of 1-heptane sulfonic acid sodium salt 

Mobile phase: Acetonitrile and Buffer (50:50). Adjust with 0.1 N sulfuric acid to a pH of 3.5. 

Standard solution: 11 µg/mL of USP Cetirizine Hydrochloride RS in Medium 

Sample solution: Pass a 20-mL portion of the solution under test through a nylon filter of 0.45-µm pore size. Discard the first 10 mL of the filtrate. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 210 nm 

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

Flow rate: 1.5 mL/min 

Injection volume: 50 µL 

Run time: 1.6 times the retention time of cetirizine 

System suitability 

Sample: Standard solution 

Suitability requirements 

Tailing 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 cetirizine hydrochloride (C₂₁H₂₅ClN₂O₃.2HCl) dissolved: 

Result = (r_U/r_S) × (C_S /L) × V × 100 

r_U = peak response from the Sample solution 

r_S = peak response from the Standard solution 

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

L = label claim (mg/Tablet) 

V = volume of Medium, 900 mL 

L = label claim (mg/Tablet) 

V = volume of Medium, 900 mL 

Tolerances: NLT 80% (Q) of the labeled amount of cetirizine hydrochloride (C₂₁H₂₅ClN₂O₃.2HCl) is dissolved. 

Test 3: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 3. 

Medium: Water; 900 mL 

Apparatus 2: 50 rpm 

Time: 30 min 

Standard solution: (L/900) mg/mL of USP Cetirizine Hydrochloride RS in water, where L is the label claim of cetirizine hydrochloride, in mg/Tablet 

Sample solution: Centrifuge a portion of the solution under test for NLT 15 min at 3000 rpm. 

Instrumental conditions 

(See Ultraviolet-Visible Spectroscopy 〈857〉.) 

Mode: UV 

Analytical wavelength: UV 231 nm 

Blank: Medium 

Path length: 1 cm 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of the labeled amount of cetirizine hydrochloride (C₂₁H₂₅ClN₂O₃.2HCl) dissolved: 

Result = (A_U/A_S) × (C_S /L) × V × 100 

_AU = absorbance of the Sample solution

_AS = absorbance of the Standard solution

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

L = label claim (mg/Tablet) 

V = volume of Medium, 900 mL 

Tolerances: NLT 80% (Q) of the labeled amount of cetirizine hydrochloride (C₂₁H₂₅ClN₂O₃.2HCl) is dissolved. Uniformity of Dosage Units 〈905〉: Meet the requirements 

5 IMPURITIES 

Change to read: 

Organic Impurities 

Solution A: 2 N sulfuric acid and water (2:33) 

Buffer: 3.4 g/L of tetrabutylammonium hydrogen sulfate in water 

Diluent: Acetonitrile, Solution A, and water (910:27:63) 

Mobile phase: Acetonitrile, Solution A, and Buffer (93:5:2) 

Standard solution: 1.5 µg/mL of USP Cetirizine Hydrochloride RS in Diluent 

Sample solution: 0.5 mg/mL of cetirizine hydrochloride in Diluent from NLT 20 powdered Tablets. [Note—Sonicate, if necessary.] Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 230 nm 

Column: 4.0-mm × 25-cm; 5-µm packing L3 

Flow rate: 0.8 mL/min 

Injection volume: 20 µL 

Run time: 2.5 times the retention time of cetirizine 

System suitability 

Sample: Standard solution 

Suitability requirements 

Tailing factor: NMT 2.0 

Relative standard deviation: NMT 10.0% 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of each impurity in the portion of Tablets taken: 

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

r_U = peak response of each impurity from the Sample solution

r_S = peak response of cetirizine from the Standard solution

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

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

F = relative response factor (see Table 1)

Acceptance criteria: See Table 1. 

Table 1 

^a 6-O-[2-(2-{4-[(4-Chlorophenyl)(phenyl)methyl]piperazin-1-yl} ethoxy)acetyl]-β-d-galactopyranosyl-(1→4)β-d-glucopyranose. 

^b 2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethanol. 

6 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in well-closed containers, and store below 30°. 

Labeling: When more than one Dissolution test is given, the labeling states the Dissolution test used only if Test 1 is not used. USP Reference Standards 〈11〉 

USP Cetirizine Hydrochloride RS