Dexamethasone Elixir
» Dexamethasone Elixir contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C22H29FO5.
Packaging and storage— Preserve in tight containers.
USP Reference standards 11
USP Dexamethasone RS Click to View Structure
Identification— Evaporate 9 mL of the Assay preparation, prepared as directed in the Assay, on a steam bath just to dryness, and dissolve the residue in 2 mL of a mixture of methylene chloride and methanol (1:1). Apply separately 5 µL of this solution and 5 µL of a solution of USP Dexamethasone RS in the mixture of methylene chloride and methanol (1:1), containing 0.5 mg per mL, to a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography 621). Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of chloroform, acetone, and glacial acetic acid (80:40:1) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots by viewing under short-wavelength UV light: the RF value of the principal spot obtained from the solution under test corresponds to that obtained from the Standard solution.
Alcohol content, Method II 611: between 3.8% and 5.7% of C2H5OH, n-propyl alcohol being used as the internal standard.
Mobile phase— Prepare a filtered and degassed mixture of water and acetonitrile (2:1). Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation— Dissolve an accurately weighed quantity of USP Dexamethasone RS in dilute methanol (1 in 2), and dilute quantitatively, and stepwise if necessary, with dilute methanol (1 in 2) to obtain a solution having a known concentration of about 0.1 mg per mL.
Assay preparation— Transfer an accurately measured volume of Elixir, freshly mixed and free from air bubbles, equivalent to about 1 mg of dexamethasone, to a 10-mL volumetric flask, dilute with water to volume, mix, and filter through a suitable membrane filter.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 30-cm column that contains packing L1. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure: the relative standard deviation for replicate injections is not more than 3.0%.
Procedure— Separately inject equal volumes (between 5 µL and 25 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of C22H29FO5 in each mL of the Elixir taken by the formula:
10(C / V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Dexamethasone RS in the Standard preparation, V is the volume, in mL, of Elixir taken, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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Topic/Question Contact Expert Committee
Monograph Domenick Vicchio, Ph.D.
Senior Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
USP35–NF30 Page 2837