Gabapentin Tablets
DEFINITION
Gabapentin Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of gabapentin (C9H17NO2).
IDENTIFICATION
• A. Infrared Absorption 
197K
197K
Sample:
Grind at least 20 Tablets to a fine powder. Use an amount of powder equivalent to 2 mg of gabapentin and 200 mg of dry potassium bromide.
• 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
Diluent:
1.2 g/L of monobasic potassium phosphate in water. Adjust with 5 N potassium hydroxide to a pH of 6.9.
Mobile phase:
Acetonitrile and Diluent (3:47)
Standard solution:
4.0 mg/mL of USP Gabapentin RS in Diluent
Sample solution:
4.0 mg/mL of gabapentin from NLT 20 finely powdered Tablets in Diluent
Chromatographic system
Mode:
LC
Detector:
UV 210 nm
Column:
4.6-mm × 25-cm; 5-µm packing L7
Flow rate:
1.2 mL/min
Injection size:
50 µL
System suitability
Sample:
Standard solution
Suitability requirements
Column efficiency:
NLT 7000 theoretical plates
Tailing factor:
NMT 2.0
Relative standard deviation:
NMT 2.0% of gabapentin
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of C9H17NO2 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 USP Gabapentin RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of gabapentin in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 711
711
Test 1
Medium:
0.06 N hydrochloric acid (51 mL of hydrochloric acid in 10 L of water); 900 mL
Apparatus 2:
50 rpm
Time:
45 min
Sample solution:
Pass a portion of the solution under test through a suitable 0.45-µm filter.
Determine the amount of C9H17NO2 dissolved by using the following method.
Mobile phase:
Prepare as directed in the Assay.
Standard solution:
0.0011 × L mg/mL of USP Gabapentin RS in the Medium, where L is the label claim in mg/Tablet
Chromatographic system:
Proceed as directed for the Assay.
Injection size:
100 µL for the Tablets labeled to contain 100, 300, or 400 mg; 50 µL for Tablets labeled to contain 600 or 800 mg
System suitability
Sample:
Standard solution
Suitability requirements
Column efficiency:
NLT 5000 theoretical plates
Tailing factor:
NMT 2.0
Relative standard deviation:
NMT 3%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C9H17NO2 dissolved:
Result = (rU/rS) × CS × (V/L) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of the Standard solution (mg/mL) |
| V | = | = volume of the Medium, 900 mL |
| L | = | = Tablet label claim in mg |
Tolerances:
NLT 80% (Q) of the labeled amount of C9H17NO2 is dissolved.
Test 2:
If the product complies with this test, the labeling indicates that the product meets USP Dissolution Test 2.
Medium, Apparatus 2, Mobile phase, Standard solution, Sample solution, Chromatographic system, and Analysis:
Proceed as directed for Test 1.
Time:
30 min
Tolerances:
NLT 80% (Q) of the labeled amount of C9H17NO2 is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
IMPURITIES
Organic Impurities
• Procedure
Diluent:
Prepare as directed in the Assay.
Solution A:
Dissolve 1.2 g of monobasic potassium phosphate in 940 mL of water. Adjust with 5 N potassium hydroxide to a pH of 6.9. Add 60 mL of acetonitrile, and stir. Filter and degas.
Solution B:
Dissolve 1.2 g of monobasic potassium phosphate in 700 mL of water. Adjust with 5 N potassium hydroxide to a pH of 6.9. Add 300 mL of acetonitrile and stir. Filter and degas.
Mobile phase:
See the gradient table below.
| Time (min) |
Solution A (%) |
Solution B (%) |
|---|---|---|
| 0.0 | 100 | 0 |
| 4.0 | 100 | 0 |
| 45.0 | 0 | 100 |
| 45.1 | 100 | 0 |
| 50.0 | 100 | 0 |
Standard solution:
0.04 mg/mL each of USP Gabapentin RS and USP Gabapentin Related Compound A RS in Diluent
Sample solution:
Equivalent to 20 mg/mL of gabapentin, from NLT 20 powdered Tablets, in Diluent. [Note—Sonication for about 30 s may be necessary. ]
Chromatographic system
Mode:
LC
Detector:
UV 210 nm
Column:
4.6-mm × 25-cm; 5-µm packing L7
Flow rate:
1.5 mL/min
Injection size:
50 µL
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 2.0 for the gabapentin peak
Relative standard deviation:
NMT 5.0% for gabapentin and gabapentin related compound A peaks
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of gabapentin related compound A in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response for gabapentin related compound A from the Sample solution |
| rS | = | = peak response for gabapentin related compound A from the Standard solution |
| CS | = | = concentration of USP Gabapentin Related Compound A RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of gabapentin in the Sample solution (mg/mL) |
Calculate the percentage of any other unspecified degradation product relative to the gabapentin content in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response for each unspecified impurity from the Sample solution |
| rS | = | = peak response for gabapentin from the Standard solution |
| CS | = | = concentration of USP Gabapentin RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of gabapentin in the Sample solution (mg/mL) |
Acceptance criteria
Gabapentin related compound A:
NMT 0.4%
Any individual unspecified impurity:
NMT 0.1%
Total impurities:
NMT 1.0%
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers. Store at controlled room temperature.
• Labeling:
When more than one Dissolution test is given, the labeling states the Dissolution test used only if Test 1 is not used.
• USP Reference Standards 11
11
USP Gabapentin RS 
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USP Gabapentin Related Compound A RS
2-Aza-spiro[4.5]decan-3-one.
C9H15NO 153.22
2-Aza-spiro[4.5]decan-3-one.
C9H15NO 153.22
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 3298
Pharmacopeial Forum: Volume No. 34(4) Page 934