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

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

Procedure

Buffer A: 0.01 M dibasic potassium phosphate (1.74 g/L of anhydrous dibasic potassium phosphate in water)

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

0.05 N hydrochloric acid: Transfer 500 mL of water into a 1000-mL volumetric flask, add 83 mL of hydrochloric acid, and dilute with water to volume. Transfer 50 mL of this solution into a 1000-mL volumetric flask and dilute with water to volume.

Mobile phase: Acetonitrile, methanol, and Buffer A (60:60:70). Adjust with 10% phosphoric acid to a pH of 7.2.

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

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

Sample solution: Transfer 10 Tablets to a 250-mL volumetric flask, add 100 mL of 0.05 N hydrochloric acid, and shake for 40 min or until the Tablets are completely disintegrated. Add 75 mL of a mixture of acetonitrile and methanol (1:1), and 20 mL of Buffer B, and mix for 5 min.

Dilute with a mixture of acetonitrile and methanol (1:1) to volume.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm. For Identi

cation B, use a diode array detector in the range of 200–400 nm.

Column: 4.6-mm × 15-cm; 5-μm packing L7

Column temperature: 25°–35°

Flow rate: 1 mL/min

Injection volume: 15 μL

System suitability

Sample: Standard solution

Suitability requirements

Capacity factor: NLT 3.5

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 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; 900 mL

Apparatus 2: 50 rpm

Time: 60 min

Standard solution: USP Loratadine RS at a known concentration in Medium

Sample solution: A filtered portion of the solution under test, suitably diluted with Medium, if necessary

Instrumental conditions

Mode: UV-Vis

Analytical wavelength: Maximum absorbance at about 280 nm

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of loratadine (C₂₂H₂₃ClN₂O₂) dissolved:

Result = (A_U/A_S) × C_S × D × V × (1/L) × 100

A_U = absorbance of the Sample solution

A_S = absorbance of the Standard solution

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

D = dilution factor for the Sample solution, if needed

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

Tolerances: NLT 80% (Q) of the labeled amount of loratadine (C H ClN O ) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

Organic Impurities

Buffer A, Buffer B, 0.05 N hydrochloric acid, Mobile phase, Diluent, and Sample solution: Proceed as directed in the Assay.

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 × 15-cm; 5-μm packing L7

Flow rate: 1 mL/min

Injection volume: 50 μL

System suitability

Sample: Standard solution

Suitability requirements

Relative standard deviation: NMT 4.0%

Analysis

Samples: Sample solution and Standard solution

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

Result = (r_U/r_S) × (C_S/C_U) × 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)

Acceptance criteria: See Table 1.

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.

^b Ethyl 4-(8-chloro-11-fluoro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl) piperidin-1-carboxylate.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers, and store between 2° and 30°. Protect from excessive moisture if packaged in blisters.

USP Reference Standards 〈11〉

USP Loratadine RS