Clindamycin Hydrochloride Oral Solution
Clindamycin Hydrochloride Oral Solution contains the equivalent of NLT 90.0% and NMT 110.0% of the labeled amount of clindamycin (C18H33ClN2O5S).
• A. The retention time of the clindamycin peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
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
Detector: UV 210 nm
Column: 4.6-mm × 25-cm; 5-µm packing L1
Flow rate: 1 mL/min
Injection size: 10 µL
Sample: Standard solution
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
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
Acceptance criteria: 90.0%110.0%
• Uniformity of Dosage Units 905: Meets the requirements for solution packaged in single-unit containers
• Deliverable Volume 698: Meets the requirements
• pH 791: 2.56.0
• 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
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2704Pharmacopeial Forum: Volume No. 31(5) Page 1350