Chloramphenicol and Hydrocortisone Acetate for Ophthalmic Suspension
» Chloramphenicol and Hydrocortisone Acetate for Ophthalmic Suspension is a sterile, dry mixture of Chloramphenicol and Hydrocortisone Acetate with or without one or more suitable buffers, diluents, and preservatives. It contains not less than 90.0 percent and not more than 130.0 percent of the labeled amount of chloramphenicol (C11H12Cl2N2O5), and not less than 90.0 percent and not more than 115.0 percent of the labeled amount of hydrocortisone acetate (C23H32O6), when constituted as directed.
Labeling
If packaged in combination with a container of solvent, label it with a warning that it is not for injection.
Identification
The retention times of the major peaks in the chromatogram of the Assay preparation correspond to that in the chromatogram of the Standard preparation as obtained in the Assay.
Sterility 71
It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791:
between 7.1 and 7.5, in an aqueous suspension containing 5 mg of chloramphenicol per mL.
Assay
Standard preparation
Transfer about 37.5 mg of USP Chloramphenicol RS and 37.5J mg of USP Hydrocortisone Acetate RS, both accurately weighed, J being the ratio of the labeled amount, in mg, of hydrocortisone acetate to the labeled amount, in mg, of chloramphenicol in the Chloramphenicol and Hydrocortisone Acetate for Ophthalmic Solution, to a 100-mL volumetric flask, add 15 mL of water and 75 mL of methanol, sonicate for a few seconds, dilute with methanol to volume, and mix. Transfer 5.0 mL of the resulting solution to a 25-mL volumetric flask, dilute with Mobile phase to volume, and mix. Filter a portion of this solution through a 0.5-µm or finer porosity filter, and use the clear filtrate as the Standard preparation.
Assay preparation
Transfer the contents of an accurately counted number of containers of Chloramphenicol and Hydrocortisone Acetate for Ophthalmic Solution, equivalent to about 37.5 mg of chloramphenicol, to a 100-mL volumetric flask with the aid of 5 mL of water for each 12.5 mg of chloramphenicol contained therein. Wash each container with methanol, and add the washings to the volumetric flask. Dilute with methanol to volume, and mix. Transfer 5.0 mL of the resulting solution to a 25-mL volumetric flask, dilute with Mobile phase to volume, and mix. Filter a portion of this solution through a 0.5-µm or finer porosity filter, and use the clear filtrate as the Assay preparation.
Procedure
Proceed as directed for Procedure in the Assay under Chloramphenicol. Calculate the quantity, in mg, of chloramphenicol (C11H12Cl2N2O5) in each container taken by the formula:
0.5(C / N)(rU / rS)
in which N is the number of containers taken, and the other terms are as defined therein. Calculate the quantity, in mg, of hydrocortisone acetate (C23H32O6) in each container taken by the formula:
500(C / N)(rU / rS)
in which C is the concentration, in mg per mL, of USP Hydrocortisone Acetate RS in the Standard preparation, N is the number of containers taken, and rU and rS are the hydrocortisone acetate peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information
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Chromatographic Column
USP32NF27 Page 1888
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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