Hydroxyzine Hydrochloride Oral Solution
» Hydroxyzine Hydrochloride Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hydroxyzine hydrochloride (C21H27ClN2O2·2HCl).
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
Identification Dilute a volume of Oral Solution, equivalent to about 20 mg of hydroxyzine hydrochloride, with 50 mL of methanol, and mix. Apply 100 µL of this solution and 100 µL of a solution in the same medium containing about 350 µg of USP Hydroxyzine Hydrochloride RS per mL to a suitable thin-layer chromatographic plate (see Chromatography 621), coated with a 0.25-mm layer of chromatographic silica gel and dried in air for 30 minutes followed by drying in vacuum at 140 for 30 minutes. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of toluene, alcohol, and ammonium hydroxide (150:95:1) 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 lightly spraying with potassium iodoplatinate TS: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
Uniformity of dosage units 905
for oral solution packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for oral solution packaged in multiple-unit containers: meets the requirements.
Mobile phase and Chromatographic system Proceed as directed in the Assay under Hydroxyzine Hydrochloride Tablets.
Standard preparation Dissolve a suitable quantity of USP Hydroxyzine Hydrochloride RS, accurately weighed, in water to obtain a solution having a known concentration of about 100 µg per mL.
Assay preparation Transfer an accurately measured volume of Oral Solution, equivalent to about 20 mg of hydroxyzine hydrochloride, to a 200-mL volumetric flask, dilute with water to volume, mix, and pass a portion through a polytef membrane filter having a 5-µm or finer porosity.
Procedure Proceed as directed for Procedure in the Assay under Hydroxyzine Hydrochloride Tablets. Calculate the quantity, in mg, of hydroxyzine hydrochloride (C21H27ClN2O2·2HCl) in each mL of the Oral Solution taken by the formula:
0.2(C/V)(rU / rS)in which C is the concentration, in µg per mL, of USP Hydroxyzine Hydrochloride RS in the Standard preparation; V is the volume, in mL, of Oral Solution taken; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 3459Pharmacopeial Forum: Volume No. 29(6) Page 1903