Chloramphenicol Capsules
Action and use
Antibacterial.
Definition
Chloramphenicol Capsules contain Chloramphenicol.
Content of chloramphenicol, C11H12Cl2N2O5
95.0 to 105.0% of the stated amount.
Identification
Suspend a quantity of the contents of the capsules containing 0.1 g of Chloramphenicol in 60 mL of water and extract with two 20-mL quantities of petroleum spirit (boiling range, 120° to 160°). Wash the combined extracts with two 15-mL quantities of water, add the washings to the aqueous layer, extract with four 50-mL quantities of ether and evaporate the combined ether extracts. The residue complies with the following tests.
1 volume of water, 10 volumes of methanol and 90 volumes of chloroform.
The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).
Tests
Dissolution
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
After 45 minutes withdraw a 10 mL sample of the medium and measure the absorbance of the filtered sample, suitably diluted with 0.1m hydrochloric acid if necessary, at the maximum at 278 nm, Appendix II B, using 0.1m hydrochloric acid in the reference cell.
Calculate the total content of chloramphenicol, C11H12Cl2N2O5, in the medium taking 297 as the value of A(1%, 1 cm) at the maximum at 278 nm.
2-Amino-1-(4-nitrophenyl)propane-1,3-diol
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
The chromatographic conditions described under Assay may be used.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks corresponding to chloramphenicol and 2-amino-1-(4-nitrophenyl)propane-1,3-diol is at least 8.0.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to 2-amino-1-(4-nitrophenyl)-propane-1,3-diol is not greater than the area of the peak in the chromatogram obtained with solution (2) (1%).
Assay
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
1 volume of glacial acetic acid, 15 volumes of acetonitrile and 85 volumes of a 0.21% w/v solution of sodium pentanesulfonate.
The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks corresponding to chloramphenicol and 2-amino-1-(4-nitrophenyl)propane-1,3-diol is at least 8.0.
Calculate the content of C11H12Cl2N2O5 in the capsules using the declared content of C11H12Cl2N2O5 in chloramphenicol BPCRS.