Vinpocetine Capsules
DEFINITION
Vinpocetine Capsules contain NLT 90.0% and NMT 110.0% of the labeled amount of vinpocetine (C22H26N2O2).
IDENTIFICATION
• A. Ultraviolet Absorption 
197U
197U
Medium:
Alcohol
Standard solution:
15 µg/mL of USP Vinpocetine RS in Medium
Sample solution:
Equivalent to 15 µg/mL of vinpocetine from Capsule contents in Medium
Acceptance criteria:
The spectra of the Sample solution and Standard solution exhibit maxima and minima at the same wavelengths.
• B. HPLC:
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in Strength.
STRENGTH
• Procedure
Solution A:
15.4 g/L of ammonium acetate in water
Mobile phase:
Acetonitrile and Solution A (55:45)
Standard solution:
0.2 mg/mL of USP Vinpocetine RS in Mobile phase
Sample solution:
Weigh NLT 20 Capsules in a tared weighing bottle. Open the Capsules, without the loss of shell material, and transfer the contents to a suitable beaker. Remove any contents adhering to the empty shells by washing, if necessary, with several portions of ether. Discard the washings, and dry the Capsule shells with the aid of a current of dry air until the odor of ether is no longer perceptible. Weigh the empty Capsule shells in the tared weighing bottle, and calculate the average net weight per Capsule. Dissolve a portion of the Capsule contents in acetonitrile with sonication for 5 min. Allow the solution to cool to room temperature, dilute with acetonitrile to get a solution with a nominal concentration of 0.2 mg/mL of vinpocetine, and filter.
Chromatographic system
Mode:
LC
Detector:
UV 280 nm
Column:
4.6-mm × 25-cm; 5-µm packing L1
Flow rate:
1.0 mL/min
Injection volume:
15 µL
System suitability
Sample:
Standard solution
Suitability requirements
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of vinpocetine (C22H26N2O2) in the portion of Capsules 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 Vinpocetine RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of vinpocetine in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Disintegration and Dissolution 2040:
Meet the requirements for Disintegration
2040:
Meet the requirements for Disintegration
• Weight Variation 2091:
Meet the requirements
2091:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers.
• USP Reference Standards 11
11
USP Vinpocetine RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Natalia Davydova
Scientific Liaison (301) 816-8328 |
(DS2010) Monographs - Dietary Supplements and Herbal Medicines |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP38–NF33 Page 6254
Pharmacopeial Forum: Volume No. 39(4)