Dexchlorpheniramine Maleate 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 

Dexchlorpheniramine Maleate Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of dexchlorpheniramine maleate (C₁₆H₁₉CIN₂ . C₄H₄O₄)

2 IDENTIFICATION 

2.1 A. Identification—Organic Nitrogenous Bases 〈181〉: Meet the requirements 

2.2 B. 

Analysis: Shake a quantity of nely powdered Tablets, equivalent to 150 mg of dexchlorpheniramine maleate, with 100 mL of 1 N acetic acid for 10 min, and lter through a sintered-glass funnel into a suitable vessel. Adjust the ltrate with sodium hydroxide solution (1 in 10) to a pH of 11, and extract the solution with six 100-mL portions of solvent hexane, ltering each hexane extract using suitable means to separate the hexane layer from the aqueous layer. Concentrate the combined extracts on a steam bath to a small volume, transfer to a smaller, more suitable vessel, and evaporate just to the point where hexane vapors are no longer perceptible. Transfer the oily residue, with the aid of four 3-mL portions of dimethylformamide, to a suitable glass-stoppered graduated cylinder, dilute with dimethylformamide to 15.0 mL, mix, and centrifuge if necessary. 

Acceptance criteria: The optical rotation of the solution so obtained in a 100-mm tube after correcting for the blank is between +0.24° and +0.35° (distinction from chlorpheniramine maleate). 

3 ASSAY 

3.1 Procedure 

Diluent: Dilute hydrochloric acid (1 in 120) 

Standard stock solution: 0.4 mg/mL of USP Dexchlorpheniramine Maleate RS in water 

Standard solution: 40 µg/mL of USP Dexchlorpheniramine Maleate RS, prepared as follows. Transfer 10.0 mL of the Standard stock solution to a separator, adjust with 1 N sodium hydroxide to a pH of 11, and cool. Extract with two 50-mL portions of solvent hexane, shaking each portion for 2 min before separating the phases, and combining the hexane extracts in a second separator. Extract the hexane solution with two 40-mL portions of Diluent, combine the Diluent extracts in a 100-mL volumetric ask, and add Diluent to volume. Filter the solution into a glass-stoppered conical ask, discarding the rst few mL of the ltrate. 

Sample solution: Nominally 40 µg/mL of dexchlorpheniramine maleate, prepared as follows. Transfer an equivalent to 8 mg of dexchlorpheniramine maleate, from NLT 20 nely powdered Tablets, to a 250-mL separator. Mix with 50 mL of water for 10 min, adjust with sodium hydroxide solution (1 in 10) to a pH of 11, and cool to room temperature. Extract the mixture with two 75-mL portions of solvent hexane, and combine the extracts in a second separator. Extract the solvent hexane solution with three 50-mL portions of Diluent, combining the Diluent extracts in a 200-mL volumetric ask. Add Diluent to volume. 

Instrumental conditions 

Analytical wavelength: Maximum absorbance at about 264 nm 

Cell: 1 cm 

Blank: Diluent 

Analysis 

Samples: Standard solution and Sample solution 

Concomitantly determine the absorbance of the Standard solution and Sample solution. 

Calculate the percentage of the labeled amount of dexchlorpheniramine maleate (C₁₆H₁₉CIN₂ . C₄H₄O₄) in the portion of Tablets taken: 

Result = (A_u/A_s) x (C_s/C_u) x 100 

A_u = absorbance of the Sample solution 

A_s = absorbance of the Standard solution 

C_s = concentration of USP Dexchlorpheniramine Maleate RS in the Standard solution (µg/mL) 

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

Acceptance criteria: 90.0%–110.0% 

4 PERFORMANCE TESTS 

4.1 Dissolution 〈711〉 

Medium: Water; 500 mL 

Apparatus 2: 50 rpm 

Time: 45 min 

Solution A: Sodium hydroxide solution (1 in 2) 

Internal standard solution: 90 µg/mL of dexbrompheniramine maleate in water 

Standard stock solution: 12.5 µg/mL of USP Dexchlorpheniramine Maleate RS in water 

Standard solution: Pipet 5 mL of the Standard stock solution into a 50-mL centrifuge tube, and add 10.0 mL water and 1.0 mL Internal standard solution. Adjust with Solution A to a pH of 11 ± 0.1, and add 3.0 mL of chromatographic hexane. Insert the stopper in the tube, shake by mechanical means for 3 min, centrifuge, and use the clear supernatant hexane layer. 

Sample solution: Pipet 15 mL of a portion of the solution under test into a 50-mL centrifuge tube, and add 1.0 mL of Internal standard solution. Adjust with Solution A to a pH of 11 ± 0.1, and add 3.0 mL of chromatographic hexane. Insert the stopper in the tube, shake by mechanical means for 3 min, centrifuge, and use the clear supernatant hexane layer. 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: GC 

Detector: Flame ionization 

Column: 2-mm × 1.8-m; contains a packing consisting of 1.2% phase G16 and 0.5% potassium hydroxide on support S1AB Temperatures 

Column: 205° 

Injector: 250° 

Detector: 250° 

Flow rate: 60 mL/min 

Carrier gas: Helium 

Injection volume: 2 µL 

System suitability 

Sample: Standard solution 

[Note—The relative retention times for dexchlorpheniramine and dexbrompheniramine are about 0.7 and 1.0, respectively.] Suitability requirements 

Resolution: NLT 1.9 between dexchlorpheniramine and dexbrompheniramine 

Relative standard deviation: NMT 2.0% 

Analysis 

Samples: Standard solution and Sample solution 

Calculate the quantity of dexchlorpheniramine maleate (C₁₆H₁₉CIN₂ . C₄H₄O₄) dissolved by comparing the peak response ratios. Tolerances: NLT 75% (Q) of the labeled amount of dexchlorpheniramine maleate (C₁₆H₁₉CIN₂ . C₄H₄O₄) is dissolved.

4.2 Uniformity of Dosage Units 〈905〉: Meet the requirements 

5 ADDITIONAL REQUIREMENTS 

5.1 Packaging and Storage: Preserve in tight containers. Store at controlled room temperature. 

5.2 USP Reference Standards 〈11〉 

USP Dexchlorpheniramine Maleate RS