Loratadine Chewable 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

Loratadine Chewable Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of loratadine (C₂₂H₂₃ClN₂O₂).

2 IDENTIFICATION

A. Thin-Layer Chromatographic Identification Test 〈201〉

Diluent: Chloroform and methanol (1:1)

Standard solution: 5 mg/mL of USP Loratadine RS in Diluent

Sample solution: Transfer a quantity of ground Chewable Tablets, equivalent to 25 mg of loratadine, to a centrifuge tube. Add 5 mL of Diluent, mix for 30 min, then centrifuge for 5 min. Use the clear supernatant.

Application volume: 5 μL

Developing solvent system: Ethyl ether and diethylamine (40:1)

Acceptance criteria: Meet the requirements

B. 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

Protect solutions containing loratadine from light.

Buffer A (phosphate buffer pH 7.2): Dissolve 4.35 g of dibasic potassium phosphate in 950 mL of water. Add 1 mL of triethylamine, adjust with 10% phosphoric acid or 10% potassium hydroxide to a pH of 7.2, and dilute with water to 1 L.

Buffer B (0.6 M dibasic potassium phosphate): 105 g/L of dibasic potassium phosphate in water

Diluent: Transfer 400 mL of 0.05 N hydrochloric acid and 80 mL of Buffer B to a 1-L volumetric flask. Dilute with a mixture of acetonitrile and methanol (1:1) to volume.

Mobile phase: Acetonitrile, methanol and Buffer A (40:10:50)

Standard solution: 0.4 mg/mL of USP Loratadine RS in Diluent

Sample solution: Nominally 0.4 mg/mL of loratadine in Diluent. Prepare by transferring 20 Chewable Tablets to a suitable volumetric flask.

Add Diluent to 40% of the volume of the flask, and shake for 40 min. Dilute with Diluent to volume, and filter.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm × 25-cm; 5-μm packing L7

Column temperature: 30°

Flow rate: 1.5 mL/min

Injection volume: 15 μL

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 loratadine (C₂₂H₂₃ClN₂O₂) in the portion of Chewable 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 Loratadine RS in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: 0.1 N hydrochloric acid; 500 mL

Apparatus 2: 50 rpm

Time: 30 min

Buffer: 6.8 g/L of monobasic potassium phosphate in water. Adjust with 10% phosphoric acid to a pH of 2.80 ± 0.05.

Mobile phase: Acetonitrile, methanol, and Buffer (40:30:35)

Standard solution: 10 μg/mL of USP Loratadine RS in Medium

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

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 220 nm

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

Column temperature: 40°

Flow rate: 1.5 mL/min

Injection volume: 20 μL

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 loratadine (C₂₂H₂₃ClN₂O₂) 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 Loratadine RS in the Standard solution (mg/mL)

L = label claim (mg/Tablet)

V = volume of Medium, 500 mL

Tolerances: NLT 80% (Q) of the labeled amount of loratadine (C₂₂H₂₃ClN₂O₂) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

Organic Impurities

Protect solutions containing loratadine from light.

Mobile phase, Diluent, and Sample solution: Prepare as directed in the Assay.

System suitability solution: 0.8 μg/mL each of USP Loratadine Related Compound A RS, USP Loratadine Related Compound B RS, and USP

Loratadine Related Compound C RS in Diluent

Standard solution: 0.8 μg/mL of USP Loratadine RS in Diluent

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm × 25-cm; 5-μm packing L7

Column temperature: 30°

Flow rate: 1.5 mL/min

Injection volume: 50 μL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Relative standard deviation: NMT 10%, Standard solution

Resolution: NLT 5.5 between loratadine related compound A and loratadine related compound C; NLT 2.0 between loratadine related compound C and loratadine related compound B, System suitability solution

Tailing factor: NMT 2.0 for loratadine related compound A, System suitability solution

Analysis

Samples: Standard solution and Sample solution

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

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

r_U = peak response of each impurity from the Sample solution

r_S = peak response of loratadine from the Standard solution

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

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

F = relative response factor (see Table 1)

Acceptance criteria: See Table 1.

Reporting level for impurities: 0.05%

Table 1

^a This is a process impurity and is included in the table for identification only. This impurity is controlled in the drug substance. It is not to be reported for the drug product and should not be included in the total impurities.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers, and store between 20° and 25°.

Labeling: Label it to indicate that the Chewable Tablets are to be chewed before swallowing.

USP Reference Standards 〈11〉

USP Loratadine RS

USP Loratadine Related Compound A RS

8-Chloro-5,6-dihydro-11-(piperidin-4-ylidene)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine.

C₁₉H₁₉ClN₂ 310.82

USP Loratadine Related Compound B RS

8-Chloro-5,6-dihydro-11-(N-methylpiperidin-4-ylidene)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine.

C₂₀H₂₁ClN₂ 324.85

USP Loratadine Related Compound C RS

8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-one.

C₁₄H₁₀ClNO 243.69