Phenylephrine 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

Phenylephrine Hydrochloride Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of phenylephrine hydrochloride (C₉H₁₃NO₂ · HCl).

2 IDENTIFICATION

A. The UV absorption spectra of the phenylephrine peak of the Sample solution and that of the Standard solution exhibit maxima and minima at the same wavelengths, as obtained in the Assay.

B. The retention time of the phenylephrine peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

Procedure

It is suggested to use plastic vials for analysis.

Buffer: 3.45 g/L of monobasic ammonium phosphate in water. Adjust with 10% phosphoric acid or 10% ammonium hydroxide solution to a pH of 4.5 ± 0.10, if necessary.

Solution A: Dilute 10 mL of glacial acetic acid with water to 1000 mL.

Mobile phase: Acetonitrile and Buffer (35:65)

Diluent: Methanol and Solution A (30:70)

Standard solution: 0.1 mg/mL of USP Phenylephrine Hydrochloride RS in Diluent

Sample solution: Nominally 0.1 mg/mL of phenylephrine hydrochloride prepared as follows. Transfer NLT 10 Tablets to a suitable volumetric flask, add 50% of the final volume of Solution A, and stir vigorously for NLT 30 min. Add 30% of the final volume of methanol and stir for NLT an additional 90 min. To ensure that particles do not collect above the solvent level, periodically rinse the particulate into the solution with Solution A. Allow the resulting solution to cool to room temperature and dilute with Solution A to volume. Pass a portion through a suitable filter of 0.45-μm pore size. Discard the first 2–3 mL of filtrate.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 214 nm. For Identification A, use a diode array detector in the range of 200–350 nm.

Column: 4.6-mm × 10-cm; 5-μm packing L9

Flow rate: 2.0 mL/min

Injection volume: 25 μL

Run time: NLT 1.75 times the retention time of phenylephrine

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: 0.5–3.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of phenylephrine hydrochloride (C₉H₁₃NO₂ · HCl) in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of phenylephrine from the Sample solution

r_S = peak response of phenylephrine from the Standard solution

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

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

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

It is suggested to use plastic vials for analysis.

Medium: Simulated gastric fluid without pepsin; 900 mL

Apparatus 2: 50 rpm

Time: 45 min

Buffer, Mobile phase, and System suitability: Proceed as directed in the Assay.

Standard solution: (L/900) mg/mL of USP Phenylephrine Hydrochloride RS in Medium, where L is the label claim of phenylephrine hydrochloride in mg/Tablet

Sample solution: Pass a portion of the solution under test through a suitable filter of 10–20-μm pore size.

Chromatographic system: Proceed as directed in the Assay, except for the following.

Injection volume: 100 μL

Run time: NLT 1.5 times the retention time of phenylephrine

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of phenylephrine hydrochloride (C₉H₁₃NO₂ · HCl) dissolved:

Result = (r_U/r_S) × C_S × V × (1/L) × 100

r_U = peak response of phenylephrine from the Sample solution

r_S = peak response of phenylephrine from the Standard solution

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

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

Tolerances: NLT 75% (Q) of the labeled amount of phenylephrine hydrochloride (C H NO · HCl) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 ADDITIONAL REQUIREMENTS

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

Change to read:

USP Reference Standards 〈11〉

USP Phenylephrine Hydrochloride RS