Vinpocetine Tablets
DEFINITION
Vinpocetine Tablets 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 finely powdered Tablets 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:
Dissolve a portion from NLT 20 finely powdered Tablets in acetonitrile by shaking thoroughly and sonicating for 5 min. Allow the solution to cool to room temperature, dilute with acetonitrile to get a solution nominally equivalent to 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 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 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 Dissolution
2040:
Meet the requirements for Dissolution
Medium:
0.1 N hydrochloric acid; 900 mL
Apparatus 1:
100 rpm
Time:
30 min
Sample solution:
Withdraw a portion of the solution under test, pass through a suitable filter, and use the pooled sample as the test specimen.
Standard solution:
Dissolve a suitable amount of USP Vinpocetine RS in Medium to obtain a concentration similar to that of the Sample solution.
Instrumental conditions
Mode:
UV absorption spectroscopy
Analytical wavelength:
UV 268 nm
Blank:
Medium
Analysis
Samples:
Sample solution and Standard solution
Calculate the percentage of the labeled amount of vinpocetine (C22H26N2O2) dissolved:
Result = (AU/AS) × [CS × (V/L)] × 100
| AU | = | = absorbance of vinpocetine from the Sample solution |
| AS | = | = absorbance of vinpocetine from the Standard solution |
| CS | = | = concentration of USP Vinpocetine RS in the Standard solution (mg/mL) |
| V | = | = volume of Medium, 900 mL |
| L | = | = label claim of vinpocetine (mg/Tablet) |
Tolerances:
NLT 75% of the labeled amount of vinpocetine (C22H26N2O2) is dissolved.
• 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 6255
Pharmacopeial Forum: Volume No. 39(4)