Clindamycin Hydrochloride Oral Solution
DEFINITION
Clindamycin Hydrochloride Oral Solution contains the equivalent of NLT 90.0% and NMT 110.0% of the labeled amount of clindamycin (C18H33ClN2O5S).
IDENTIFICATION
• A.
The retention time of the clindamycin peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Buffer:
6.8 g/L of monobasic potassium phosphate in water. Adjust with 8 N potassium hydroxide to a pH of 7.5.
Mobile phase:
Acetonitrile and Buffer (450:550). Increasing the proportion of acetonitrile in the Mobile phase decreases the retention time, and decreasing it increases the resolution between 7-epiclindamycin and clindamycin.
Standard solution:
1 mg/mL of USP Clindamycin Hydrochloride RS in Mobile phase
Sample solution:
Equivalent to 0.85 mg/mL of clindamycin from Oral Solution in Mobile phase
Chromatographic system
Mode:
LC
Detector:
UV 210 nm
Column:
4.6-mm × 25-cm; 5-µm packing L1
Flow rate:
1 mL/min
Injection size:
10 µL
System suitability
Sample:
Standard solution
Suitability requirements
Resolution:
NLT 2.4 between the clindamycin B and 7-epiclindamycin peaks, and NLT 3.0 between the 7-epiclindamycin and clindamycin peaks
Column efficiency:
NLT 4000 theoretical plates from the clindamycin peak
Tailing factor:
NMT 1.2 for the clindamycin peak
Relative standard deviation:
NMT 1.0% for the clindamycin peak
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of clindamycin (C18H33ClN2O5S) in each mL of Oral Solution taken:
Result = (rU/rS) × (CS/CU) × P × F × 100
| rU | = | = peak area response from the Sample solution |
| rS | = | = peak area response from the Standard solution |
| CS | = | = concentration of USP Clindamycin Hydrochloride RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of clindamycin in the Sample solution (mg/mL) |
| P | = | = potency of clindamycin in USP Clindamycin Hydrochloride RS (µg/mg) |
| F | = | = conversion factor, 0.001 mg/µg |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Uniformity of Dosage Units 
905
:
Meets the requirements for solution packaged in single-unit containers
905:
Meets the requirements for solution packaged in single-unit containers
• Deliverable Volume 698:
Meets the requirements
698:
Meets the requirements
SPECIFIC TESTS
• pH 791:
2.5–6.0
791:
2.5–6.0
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• Labeling:
Label Oral Solution to indicate that it is intended for veterinary use only.
• USP Reference Standards 11
11
USP Clindamycin Hydrochloride RS 
') + '&img=../../images/v35300/cas-21462-39-5.gif',600,500);)
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2704
Pharmacopeial Forum: Volume No. 31(5) Page 1350