Ticlopidine Hydrochloride Tablets
DEFINITION
Ticlopidine Hydrochloride Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of ticlopidine hydrochloride C14H14ClNS·HCl.
IDENTIFICATION
• A. Ultraviolet Absorption 
197U
:
Place a portion of powdered Tablets, equivalent to 100 mg of ticlopidine hydrochloride, in a suitable flask. Add 1 mL of water, and allow to stand for 15 min with occasional shaking. Add about 60 mL of Mobile phase, sonicate for 15 min, and shake by mechanical means for an additional 15 min. Dilute with Mobile phase to volume, and mix. Dilute a portion of this solution with Mobile phase to prepare 0.1 mg/mL of ticlopidine hydrochloride.
197U:
Place a portion of powdered Tablets, equivalent to 100 mg of ticlopidine hydrochloride, in a suitable flask. Add 1 mL of water, and allow to stand for 15 min with occasional shaking. Add about 60 mL of Mobile phase, sonicate for 15 min, and shake by mechanical means for an additional 15 min. Dilute with Mobile phase to volume, and mix. Dilute a portion of this solution with Mobile phase to prepare 0.1 mg/mL of ticlopidine hydrochloride.
Acceptance criteria:
The UV absorption spectra of the solution exhibits maxima at the same wavelength (232 nm) as that of a similar solution prepared from USP Ticlopidine Hydrochloride RS, concomitantly measured.
• 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
Buffer:
3.55 g/L of dibasic sodium phosphate
Mobile phase:
Acetonitrile and Buffer (3:2). Adjust with phosphoric acid to a pH of 7.0 ± 0.1.
Standard solution:
0.1 mg/mL of USP Ticlopidine Hydrochloride RS in Mobile phase
Sample solution:
Weigh and finely powder NLT 20 Tablets. Transfer a portion of the powder, equivalent to about 250 mg of ticlopidine hydrochloride to a 250-mL volumetric flask, add 150 mL of Mobile phase, sonicate for about 5 min, and shake mechanically for 10 additional min. Dilute with Mobile phase to volume, and mix. Pass a portion of this solution through a suitable 0.45-µm filter, and use the filtrate after discarding the first few mL. Transfer 5 mL of the filtrate into a 50-mL volumetric flask, and dilute with Mobile phase to volume.
Chromatographic system
Mode:
LC
Detector:
UV 228 nm
Column:
3.9-mm × 30-cm; 5-µm packing L1
Column temperature:
40
Flow rate:
1.5 mL/min
Injection size:
15 µL
Run time:
Twice the retention time of the ticlopidine peak
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 2.0
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C14H14ClNS·HCl in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of ticlopidine from the Sample solution |
| rS | = | = peak response of ticlopidine from the Standard solution |
| CS | = | = concentration of USP Ticlopidine Hydrochloride RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of ticlopidine hydrochloride in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution
Medium:
Water; 900 mL, deaerated
Apparatus 2:
50 rpm
Time:
45 min
Standard solution:
0.278 mg/mL of USP Ticlopidine Hydrochloride RS in Medium
Sample solution:
Pass a portion of the solution under test through a suitable filter.
Detection:
UV 232 nm
Path length:
0.1 cm
Blank:
Medium
Calculate the percentage of C14H14ClNS·HCl 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 (mg) |
| V | = | = volume of Medium, 900 mL |
Tolerances:
NLT 75% (Q) of the labeled amount of C14H14ClNS·HCl is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers and stored at controlled room temperature.
• USP Reference Standards 11
11
USP Ticlopidine Hydrochloride 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 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4867
Pharmacopeial Forum: Volume No. 35(3) Page 584