Cyclobenzaprine Hydrochloride Tablets
DEFINITION
Cyclobenzaprine Hydrochloride Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of cyclobenzaprine hydrochloride (C20H21N·HCl).
IDENTIFICATION
• A. Infrared Absorption 
197M
197M
Sample:
Transfer an amount equivalent to 50 mg of cyclobenzaprine hydrochloride, from a quantity of finely powdered Tablets, to a small flask. Add 10 mL of methylene chloride, swirl to dissolve, and filter. Evaporate the clear filtrate to about 5 mL, transfer to a centrifuge tube, and add 1–2 mL of ether. Evaporate with the aid of a current of air to about 1 mL, and agitate until crystallization occurs. Wash the crystals with several portions of ether, and air-dry.
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.
ASSAY
• Procedure
Mobile phase:
Acetonitrile, methanol, methanesulfonic acid, and water (28: 24: 0.2: 48). Adjust with diethylamine to a pH of 3.6.
Standard solution:
0.05 mg/mL of USP Cyclobenzaprine Hydrochloride RS in 0.1 N hydrochloric acid
Sample solution:
Nominally 0.05 mg/mL of cyclobenzaprine hydrochloride from finely powdered Tablets (NLT 20) in 0.1 N hydrochloric acid prepared as follows. Transfer a suitable amount of the powder to a suitable volumetric flask. Add 75% of the flask volume of 0.1 N hydrochloric acid, and shake by mechnical means for 30 min. Dilute with 0.1 N hydrochloric acid to volume.
Chromatographic system
Mode:
LC
Detector:
UV 290 nm
Column:
4.6-mm × 10-cm; packing L1
Flow rate:
1.5 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Capacity factor:
NLT 2.0
Column efficiency:
NLT 1000 theoretical plates
Tailing factor:
NMT 2
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of cyclobenzaprine hydrochloride (C20H21N·HCl) in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of the Standard solution (mg/mL) |
| CU | = | = nominal concentration of cyclobenzaprine hydrochloride in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 711
711
Medium:
0.1 N hydrochloric acid; 900 mL
Apparatus 1:
50 rpm
Time:
30 min
Standard solution:
USP Cyclobenzaprine Hydrochloride RS in Medium having a concentration similar to the one expected in the Sample solution
Sample solution:
Pass a portion of the solution under test through a suitable filter, and dilute with Medium if necessary.
Instrumental conditions
Mode:
UV
Analytical wavelength:
290 nm
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of cyclobenzaprine hydrochloride (C20H21N·HCl) dissolved.
Tolerances:
NLT 75% (Q) of the labeled amount of cyclobenzaprine hydrochloride (C20H21N·HCl) is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
• USP Reference Standards 11
11
USP Cyclobenzaprine 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 | Ravi Ravichandran, Ph.D.
Principal Scientific Liaison 1-301-816-8330 |
(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 2786
Pharmacopeial Forum: Volume No. 27(2) Page 2135