Methylphenidate Hydrochloride Tablets
DEFINITION
Methylphenidate Hydrochloride Tablets contain NLT 93.0% and NMT 107.0% of the labeled amount of methylphenidate hydrochloride (C14H19NO2·HCl).
IDENTIFICATION
• A. Infrared Absorption 
197M
197M
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
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
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%
PERFORMANCE TESTS
• Dissolution 711, Procedure for a Pooled Sample
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
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• USP Reference Standards 11
11
USP Methylphenidate Hydrochloride RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Hariram Ramanathan, M.S.
Associate Scientific Liaison 1-301-816-8313 |
(SM42010) Monographs - Small Molecules 4 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3881
Pharmacopeial Forum: Volume No. 33(2) Page 246