Cetirizine 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)

DOWNLOAD PDF HERE

1 DEFINITION 

Cetirizine Hydrochloride Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of 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. B. Identification Tests—General, Chloride〈191〉: Meets the requirements 

3 ASSAY 

Procedure 

Solution A: Acetonitrile 

Solution B: 1.36 g/L of monobasic potassium phosphate in water. Adjust with a 2% solution of phosphoric acid in water to a pH of 3.5 ± 0.05. Diluent: Acetonitrile and water (3:7) 

Mobile phase: See the gradient table below. 

Standard stock solution: 5 mg/mL of USP Cetirizine Hydrochloride RS in water 

Standard solution: 0.1 mg/mL of USP Cetirizine Hydrochloride RS in Diluent, from the Standard stock solution 

Sample solution: Transfer an amount of Oral Solution to a suitable volumetric flask to obtain a nominal concentration of 0.1 mg/mL of cetirizine hydrochloride. Dissolve in 60% of the ask volume of Diluent by swirling. Sonicate 3 min, and dilute with Diluent to volume. Pass through a suitable filter. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 233 nm 

Column: 4.6-mm × 25-cm; 5-µm packing L10 

Column temperature: 50° 

Flow rate: 2 mL/min 

Injection size: 20 µL 

System suitability 

Sample: Standard solution 

Suitability requirements 

Tailing factor: NMT 1.5 

Relative standard deviation: NMT 1.0% 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of C₂₁H₂₅ClN₂O₃.2HCl in the portion of Oral Solution 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 

Deliverable Volume 〈698〉: Meets the requirements 

5 IMPURITIES 

Organic Impurities 

Procedure 

Solution A: Transfer 50 mL of water to a 100-mL volumetric ask, add 5.5 mL of sulfuric acid, and dilute with water to volume. Mobile phase: Acetonitrile, water, and Solution A (965:33:1) 

Diluent: Acetonitrile and water (7:13) 

Standard solution: 6 µg/mL of USP Cetirizine Hydrochloride RS in Diluent 

Sample solution: 0.6 mg/mL of cetirizine hydrochloride in Diluent. Transfer an amount of Oral Solution to a suitable volumetric flask, dissolve in Diluent, sonicate for 10 min, and dilute with Diluent to volume. Pass through a suitable filter. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 230 nm 

Column: 4.6-mm × 25-cm; 5-µm packing L3 

Column temperature: 30° 

Flow rate: 2 mL/min 

Injection size: 10 µL 

System suitability 

Sample: Standard solution 

Suitability requirements 

Column efficiency: NLT 10,000 theoretical plates 

Tailing factor: NMT 1.5 

Relative standard deviation: NMT 5.0% 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of each impurity in the portion of Oral Solution taken: 

Result = (r_U/r_S) × (C_S/C_U) × 100 

r_U = peak response for each imputrity 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) Acceptance criteria: See Impurity Table 1. 

Total impurities: NMT 0.8% 

Impurity Table 1 

^a 2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]acetic acid.

^b P = Process impurity. Provided for information only; the content is not calculated and not reported. The content is controlled in the drug substance monograph. 

^c 2-[2-[4-[(2-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid. 

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

^e 2-[2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy] ethoxy]acetic acid (ethoxycetirizine). 

^f 1-[(4-Chlorophenyl)phenylmethyl]piperazine. 

^g 2-Hydroxypropyl 2-(2-{4-[(4-chlorophenyl)phenylmethyl]piperazin-1-yl}ethoxy)acetate. 

^h 2-{2-[4-(Diphenylmethyl)piperazin-1-yl]ethoxy]acetic acid. 

ⁱ 2,3-Dihydroxypropyl 2-(2-{4-[(4-chlorophenyl)phenylmethyl]piperazin-1-yl}ethoxy)acetate. 

6 SPECIFIC TESTS 

pH 〈791〉: 4.0–5.1 

Microbial Enumeration Tests 〈61〉andTests for Specified Microorganisms 〈62〉: The total aerobic microbial count does not exceed 100 cfu/mL, and the total combined molds and yeasts count does not exceed 10 cfu/mL. It meets the requirements of the tests for absence of Escherichia coli. 

7 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in well-closed containers, and protect from light. Store at controlled room temperature or in a cold place. USP Reference Standards 〈11〉 

USP Cetirizine Hydrochloride RS