Meperidine 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)

DOWNLOAD PDF HERE

1 DEFINITION

Meperidine Hydrochloride Tablets contain NLT 95.0% and NMT 105.0% of the labeled amount of meperidine hydrochloride (C₁₅H₂₁NO₂ · HCl).

2 IDENTIFICATION

A. Identification—Organic Nitrogenous Bases 〈181〉

Sample solution: Transfer an amount nominally equivalent to about 50 mg of meperidine hydrochloride from powdered Tablets to a separator, add 10 mL of water, and shake. Add 5 mL of saturated sodium chloride solution and 1 mL of sodium hydroxide solution (1 in 25). Extract with three 20-mL portions of chloroform, filtering the extracts through cotton overlaid with anhydrous sodium sulfate. Evaporate the chloroform on a steam bath, and dissolve the residue in 4 mL of carbon disulfide.

Standard solution: In a second separator, proceed as directed in the Sample solution, using 50 mg of USP Meperidine Hydrochloride RS.

Analysis: Proceed as directed in the chapter, beginning with “Determine the absorption spectra”.

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

Solution A: Transfer about 6.8 g of monobasic potassium phosphate to a 1000-mL volumetric flask. Dissolve in and dilute with water to volume. Add 10 mL of triethylamine, and mix. Adjust with phosphoric acid to a pH of 7.0, and filter.

Mobile phase: Acetonitrile and Solution A (550:450), filtered and degassed

Standard stock solution: 0.6 mg/mL of USP Meperidine Hydrochloride RS in water

Standard solution: 0.12 mg/mL of USP Meperidine Hydrochloride RS from the Standard stock solution in Mobile phase

Sample stock solution: Transfer an amount nominally equivalent to about 60 mg of meperidine hydrochloride from NLT 20 finely powdered

Tablets to a 100-mL volumetric flask. Add about 70 mL of Mobile phase, and sonicate for 10 min with occasional shaking. Shake by mechanical means for about 30 min, dilute with Mobile phase to volume, mix, and filter.

Sample solution: Nominally equivalent to 0.12 mg/mL of meperidine hydrochloride in Mobile phase from the Sample stock solution

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 230 nm

Column: 3.9-mm × 30-cm; packing L1

Flow rate: 1 mL/min

Injection volume: 20 μL

System suitability

Sample: Standard solution

Suitability requirements

Column efficiency: NLT 2000 theoretical plates

Tailing factor: NMT 2 for the meperidine peak

Relative standard deviation: NMT 2%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of meperidine hydrochloride (C₁₅H₂₁NO₂ · HCl) in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of meperidine from the Sample solution

r_S = peak response of meperidine from the Standard solution

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

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

Acceptance criteria: 95.0%–105.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: Water; 500 mL

Apparatus 1: 100 rpm

Time: 45 min

Standard solution: A known concentration of USP Meperidine Hydrochloride RS in Medium

Sample solution: Filter portions of the solution under test, and suitably dilute with Medium, if necessary.

Chromatographic system and System suitability: Proceed as directed in the Assay.

Analysis: Determine the labeled amount of meperidine hydrochloride (C₁₅H₂₁NO₂ · HCl) dissolved by comparing the peak response of meperidine from the Sample solution with that from the Standard solution.

Tolerances: NLT 75% (Q) of the labeled amount of meperidine hydrochloride (C₁₅H₂₁NO₂ · HCl) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed, light-resistant containers.

USP Reference Standards 〈11〉

USP Meperidine Hydrochloride RS