Methylphenidate 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

Methylphenidate Hydrochloride Tablets contain NLT 93.0% and NMT 107.0% of the labeled amount of Methylphenidate hydrochloride (C₁₄H₁₉NO₂ · HCl).

2 IDENTIFICATION

Change to read:

A. ▲Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197M▲ (CN 1-May-2020)

Sample: Equivalent to 50 mg of methylphenidate hydrochloride from a portion of powdered Tablets in a 40-mL centrifuge tube. Add 10 mL of

chloroform, shake, and centrifuge. Filter the clear extract through a medium-sized sintered-glass funnel into a beaker, and repeat the

extraction with an additional 10-mL portion of chloroform. Evaporate the combined chloroform extracts on a steam bath to dryness. Agitate

the dried residue with 2 mL of acetonitrile, and filter the mixture through a small sintered-glass funnel. Wash the crystals with an additional

2 mL of acetonitrile, and dry them with the aid of suction.

Acceptance criteria: Meet the requirements

3 ASSAY

Procedure

Buffer: Dissolve 1.6 g of anhydrous sodium acetate in 900 mL of water. Adjust with acetic acid to a pH of 4.0. Dilute with water to 1 L.

Mobile phase: Methanol, acetonitrile, and Buffer (4:3:3)

Internal standard solution: 0.4 mg/mL of Phenylephrine hydrochloride in Mobile phase

Standard stock solution: 0.2 mg/mL of USP Methylphenidate Hydrochloride RS in Mobile phase

Standard solution: Mix 10.0 mL of the Standard stock solution with 5.0 mL of the Internal standard solution

Sample stock solution: 0.2 mg/mL of methylphenidate hydrochloride from finely powdered Tablets (NLT 20 Tablets) prepared as follows.

Dissolve in Mobile phase using 70% of the final volume. Sonicate for 15 min, and cool to room temperature. Dilute with Mobile phase to

volume. Pass a portion of this solution through a suitable membrane filter, discarding the first portion of the filtrate. Avoid the use of glass

filters. Polypropylene filters are suitable for use.

Sample solution: Mix 10.0 mL of the clear filtrate from the Sample stock solution with 5.0 mL of the Internal standard solution.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 210 nm

Column: 4.6-mm × 25-cm; packing L10

Flow rate: 1.5 mL/min

Injection size: 50 µL

System suitability

Sample: Standard solution

[Note—The relative retention times for phenylephrine hydrochloride and methylphenidate hydrochloride are 0.8 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 2.0 between the analyte and the internal standard peaks

Relative standard deviation: NMT 2.0% from the peak response ratios of the analyte to the internal standard

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of methylphenidate hydrochloride (C₁₄H₁₉NO₂ · HCl) in the portion of Tablets taken:

Result = (Rᵤ / Rₛ) × (Cₛ / Cᵤ) × 100

Rᵤ = peak response ratio of the analyte to the internal standard from the Sample solution

Rₛ = peak response ratio of the analyte to the internal standard from the Standard solution

Cₛ = concentration of USP Methylphenidate Hydrochloride RS in the Standard solution (mg/mL)

Cᵤ = nominal concentration of Methylphenidate Hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 93.0%–107.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉, Procedure for a Pooled Sample

Medium: Water; 900 mL

Apparatus 1: 100 rpm

Time: 45 min

Analysis: Determine the amount of methylphenidate hydrochloride (C₁₄H₁₉NO₂ · HCl) dissolved by using the procedure in the Assay, making

any necessary volumetric adjustments.

Tolerances: NLT 75% (Q) of the labeled amount of C₁₄H₁₉NO₂ · HCl is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Methylphenidate Hydrochloride RS