Cilostazol Tablets
DEFINITION
Cilostazol Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of cilostazol (C20H27N5O2).
IDENTIFICATION
• A. Infrared Absorption 
197S
197S
Standard solution:
100 mg/mL of USP Cilostazol RS in chloroform
Sample solution:
Transfer the equivalent of 100 mg of cilostazol from finely powdered Tablets into a glass container. Add 1 mL of chloroform, shake for 1 min, and pass through a suitable filter of 0.5-µm or finer pore size.
• B.
The retention time of the cilostazol peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Mobile phase:
Acetonitrile, methanol, and water (7:3:10)
Internal standard solution:
4 mg/mL of benzophenone in methanol
Standard solution:
0.1 mg/mL of USP Cilostazol RS and 0.04 mg/mL of Internal standard solution in methanol
Sample solution:
Transfer the equivalent of 50 mg of cilostazol from powdered Tablets (NLT 20) into a suitable volumetric flask and add an appropriate quantity of Internal standard solution. Dilute with methanol to obtain a solution of 0.1 mg/mL of USP Cilostazol RS and 0.04 mg/mL of the internal standard. Pass a portion of this solution through a membrane filter of 0.5-µm or finer pore size, and use the filtrate.
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
4.6-mm × 15-cm; packing L1
Flow rate:
1 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Resolution:
NLT 9.0 between the cilostazol and benzophenone peaks, eluted in this order
Relative standard deviation:
NMT 1.5%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of cilostazol (C20H27N5O2) in the portion of Tablets taken:
Result = (RU/RS) × (CS/CU) × 100
| RU | = | = peak response ratio of cilostazol to the internal standard from the Sample solution |
| RS | = | = peak response ratio of cilostazol to the internal standard from the Standard solution |
| CS | = | = concentration of USP Cilostazol RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of cilostazol in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 711
711
Test 1
Medium:
0.30% sodium lauryl sulfate in water; 900 mL
Apparatus 2:
75 rpm
Time:
60 min
Standard solution:
0.28 mg of USP Cilostazol RS in methanol. Dilute this solution with Medium to obtain a solution with a final concentration of about 56 µg/mL.
Sample solution:
Pass NLT 20 mL of the solution under test through a suitable filter of 0.45-µm pore size, discarding the first 10 mL. Dilute with Medium to obtain a final theoretical concentration of about 56 µg/mL, considering complete dissolution of the label claim.
Wavelength:
UV 257 nm
Path length:
1 cm
Blank:
Medium
Calculate the percentage of cilostazol dissolved:
Result = (AU/AS) × (CS/L) × V × 100
| AU | = | = absorbance of the Sample solution |
| AS | = | = absorbance of the Standard solution |
| CS | = | = concentration of the Standard solution (mg/mL) |
| L | = | = Tablet label claim |
| V | = | = volume of Medium, 900 mL |
Tolerances:
NLT 80% (Q) of the labeled amount of cilostazol is dissolved.
Test 2:
If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.
Medium:
0.3% sodium lauryl sulfate in water; 900 mL, deaerated
Apparatus 2:
75 rpm
Time:
30 min
Standard solution:
Prepare a solution containing 1.1 mg/mL of USP Cilostazol RS in methanol. Dilute this solution with 0.5% sodium lauryl sulfate in water to obtain a final concentration of (L/900) mg/mL, where L is the Tablet label claim in mg.
Sample solution:
Pass a portion of the solution under test through a suitable filter.
Wavelength:
UV 258 nm
Path length:
0.2 cm
Blank:
Medium
Tolerances:
NLT 75% (Q) of the labeled amount of cilostazol is dissolved.
Test 3:
If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 3.
Medium:
0.3% sodium lauryl sulfate in water; 900 mL
Apparatus 2:
75 rpm
Time:
60 min
Standard solution, Sample solution, Wavelength, Path length, and Blank:
Proceed as directed for Test 1.
Tolerances:
NLT 70% (Q) of the labeled amount of cilostazol is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight and light-resistant 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 Cilostazol RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Sujatha Ramakrishna, Ph.D.
Senior Scientific Liaison 1-301-816-8349 |
(SM22010) Monographs - Small Molecules 2 |
| 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 2664
Pharmacopeial Forum: Volume No. 33(3) Page 395