Clindamycin Hydrochloride Capsules
DEFINITION
Clindamycin Hydrochloride Capsules contain the equivalent of NLT 90.0% and NMT 120.0% of the labeled amount of clindamycin (C18H33ClN2O5S).
IDENTIFICATION
• A.
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, relative to the internal standard, as obtained in the Assay.
ASSAY
• Procedure
Mobile phase:
Add 2 g of dl-10-camphorsulfonic acid, 1 g of ammonium acetate, and 1 mL of glacial acetic acid to 200 mL of water in a 500-mL volumetric flask, and mix to dissolve. Dilute with methanol to volume, and mix. Adjust, if necessary, with hydrochloric acid or a sodium hydroxide solution (1 in 2) to a pH of 6.0 ± 0.1.
Internal standard solution:
Add 0.5 mL of phenylethyl alcohol to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Standard solution:
18 mg/mL of USP Clindamycin Hydrochloride RS in Internal standard solution
Sample solution:
Equivalent to 15 mg/mL of clindamycin, from the contents of NLT 20 Capsules, in Internal standard solution; shake for 30 min; centrifuge or filter, if necessary, to obtain a clear solution.
Chromatographic system
Mode:
LC
Detector:
Refractive index
Column:
4-mm × 30-cm stainless steel; packing L1
Flow rate:
1 mL/min
Injection size:
25 µL
System suitability
Sample:
Standard solution
[Note—The relative retention times for the internal standard and clindamycin are 0.6 and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 5.0 between the analyte and internal standard
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of clindamycin (C18H33ClN2O5S) in the portion of Capsules taken:
Result = (RU/RS) × (CS/CU) × P × F × 100
| RU | = | = peak response ratio of clindamycin to the internal standard from the Sample solution |
| RS | = | = peak response ratio of clindamycin to the internal standard 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%–120.0%
PERFORMANCE TESTS
• Dissolution 
711
711
Medium:
pH 6.8 phosphate buffer (see Reagents, Indicators, and Solutions—Buffer Solutions); 900 mL
Apparatus 1:
100 rpm
Time:
30 min
Mobile phase:
Dissolve 16 g of dl-10-camphorsulfonic acid, 8 g of ammonium acetate, and 8 mL of glacial acetic acid in 1600 mL of water. Add 2400 mL of methanol, and adjust with hydrochloric acid or 5 N sodium hydroxide to a pH of 6.0 ± 0.05.
Sample solution:
Pass a portion of the solution under test through a suitable filter. Dilute with Medium, if necessary.
Standard solution:
Prepare a solution of USP Clindamycin Hydrochloride RS in Medium having a known concentration similar to that expected in the Sample solution.
Chromatographic system
Mode:
LC
Detector:
Refractive index
Column:
3-µm packing L1
Flow rate:
2 mL/min
Injection size:
50 µL
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 2.0
Relative standard deviation:
NMT 3.0%
Analysis
Samples:
Sample solution and Standard solution
Calculate the amount of clindamycin (C18H33ClN2O5S) dissolved.
Tolerances:
NLT 80% (Q) of the labeled amount of clindamycin (C18H33ClN2O5S) is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
SPECIFIC TESTS
• Water Determination, Method I 921:
NMT 7.0%
921:
NMT 7.0%
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• 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 |
| 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 2703
Pharmacopeial Forum: Volume No. 28(4) Page 1090