Glucosamine Tablets
DEFINITION
Glucosamine Tablets are prepared from Glucosamine Hydrochloride, Glucosamine Sulfate Sodium Chloride, Glucosamine Sulfate Potassium Chloride, or a mixture of any of them. Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of glucosamine (C6H13NO5).
IDENTIFICATION
• A.
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the test for Content of Glucosamine.
• B. Identification TestsGeneral, Chloride 191:
Meets the requirements
• C. Identification TestsGeneral, Sulfate 191:
Meets the requirements. [NoteOnly for Tablets labeled as containing glucosamine sodium sulfate or glucosamine potassium sulfate ]
STRENGTH
• Content of Glucosamine
Buffer:
In a 1-L volumetric flask dissolve 3.5 g of dibasic potassium phosphate in water. Add 0.25 mL of ammonium hydroxide, dilute with water to volume, and mix. Adjust with phosphoric acid to a pH of 7.5.
Mobile phase:
Acetonitrile and Buffer (75:25)
Diluent:
Acetonitrile and water (50:50)
Standard solution:
3.75 mg/mL of USP Glucosamine Hydrochloride RS in Diluent
Sample solution:
Weigh and finely powder NLT 20 Tablets. Transfer an accurately weighed portion of the finely powdered material, equivalent to about 312 mg of glucosamine, to a 100-mL volumetric flask. Add 60 mL of Diluent, and sonicate for 10 min. Shake by mechanical means for 15 min. Dilute with Diluent to volume, and mix. Pass a portion of this solution through a membrane filter of 0.45-µm or finer pore size.
Chromatographic system
Mode:
LC
Detector:
UV 195 nm
Column:
4.6-mm × 15-cm; 5-µm packing L8
Column temperature:
35
Flow rate:
1.5 mL/min
Injection size:
10 µL
[NoteThe peak for glucosamine moiety elutes at about 10 min. The chromatogram shows a large additional peak near the void volume, due to the chloride ion. ]
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 2.0 for the glucosamine peak
Column efficiency:
NLT 1500 theoretical plates
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of glucosamine (C6H13NO5) in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
Acceptance criteria:
90.0%110.0%
PERFORMANCE TESTS
• Disintegration and Dissolution of Dietary Supplements 2040:
Meet the requirements for Dissolution
Medium:
Water; 900 mL
Apparatus 2:
75 rpm
Time:
60 min
Standard solution:
Dissolve a suitable amount of USP Glucosamine Hydrochloride RS in water to obtain a concentration similar to that expected in the Sample solution.
Sample solution:
Filtered portion of the solution under test
Buffer:
Mix 1.0 mL of phosphoric acid with 2 L of water, and adjust with potassium hydroxide to a pH of 3.0.
Mobile phase:
Acetonitrile and Buffer (2:3)
Chromatographic system
Mode:
LC
Detector:
UV 195 nm
Column:
4.6-mm × 25-cm; packing L7
Flow rate:
0.6 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 2.0 for the glucosamine peak
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of glucosamine (C6H13NO5) dissolved:
Result = (rU/rS) × (CS × V/L) × (Mr1/Mr2) × 100
Tolerances:
NLT 75% of the labeled amount of glucosamine (C6H13NO5) is dissolved.
• Weight Variation of Dietary Supplements 2091:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers.
• Labeling:
The label indicates the type of glucosamine salt contained in the article.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 1335
Pharmacopeial Forum: Volume No. 32(4) Page 1137
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