Hydroxyzine Hydrochloride Tablets
»Hydroxyzine Hydrochloride Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C21H27ClN2O2·2HCl.
Packaging and storage— Preserve in tight containers.
Add the following:
Labeling— When more than one Dissolution test is given,the labeling states the Dissolution test used only if Test 1is not used.USP28
Identification— Triturate a quantity of finely powdered Tablets,equivalent to about 100mg of hydroxyzine hydrochloride,with 50mLof methanol,and filter.Apply 100µLof this solution and 100µLof a solution in the same medium containing 2mg of USP Hydroxyzine Hydrochloride RSper mLto a suitable thin-layer chromatographic plate (seeChromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel and dried in air for 30minutes followed by drying in vacuum at 140for 30minutes.Proceed as directed in theIdentification test underHydroxyzine Hydrochloride Syrup,beginning with “Allow the spots to dry.”
Change to read:
Dissolution á711ñ—
TEST1—
Medium: water,900mL.
Apparatus 2: 50rpm.
Time: 45minutes.
Procedure— Determine the amount of C21H27ClN2O2·2HCl dissolved by employing UVabsorption at the wavelength of maximum absorbance at about 230nm on filtered portions of the solution under test,suitably diluted with Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Hydroxyzine Hydrochloride RSin the sameMedium.Calculate the amount of C21H27ClN2O2·2HCl dissolved per Tablet.
Tolerances— Not less than 75%(Q)of the labeled amount of C21H27ClN2O2·2HCl is dissolved in 45minutes.
TEST2— If the product complies with this test,the labeling indicates that it meets USPDissolution Test 2.
Medium: water,250mL.
Apparatus 3(see Drug Release á724ñ): 30dips per minute.
Time: 45minutes.
Procedure— Determine the amount of C21H27ClN2O2·2HCl dissolved by employing UVabsorption at the wavelength of maximum absorbance at about 230nm on filtered portions of the solution under test,suitably diluted with Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Hydroxyzine Hydrochloride RSin the sameMedium.Calculate the amount of C21H27ClN2O2·2HCl dissolved per Tablet.
Tolerances— Not less than 75%(Q)of the labeled amount of C21H27ClN2O2·2HCl is dissolved in 45minutes.
USP28
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Mobile phase— Dissolve 6.8g of monobasic potassium phosphate in 1000mLof water,add 1000mLof methanol,and mix.Filter the solution through a polytef membrane filter (5µm or finer porosity),and degas.
Standard preparation— Dissolve a suitable quantity of USP Hydroxyzine Hydrochloride RS,accurately weighed,in methanol to obtain a solution having a known concentration of about 100µg per mL.
Assay preparation— Place 20Tablets in a high-speed blender jar containing 400.0mLof methanol,and blend for 5minutes.The Tablets are completely disintegrated.Allow to settle,and filter a portion of the supernatant through a polytef membrane filter (1-µm or finer porosity).Dilute an accurately measured volume of the filtrate so obtained quantitatively with methanol to obtain anAssay preparation having a concentration of about 100µg of hydroxyzine hydrochloride per mL.
Chromatographic system (see Chromatography á621ñ)— The liquid chromatograph is equipped with a 232-nm detector and a 4.6-mm ×25-cm column that contains packing L9.The flow rate is about 2.0mLper minute.Chromatograph theStandard preparation,and record the peak responses as directed forProcedure:the relative standard deviation is not more than 2.5%.
Procedure— Separately inject equal volumes (about 20µL)of theStandard preparationand theAssay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of C21H27ClN2O2·2HCl in each Tablet taken by the formula:
(L/D)(C)(rU/rS),
in whichLis the labeled quantity,in mg,of hydroxyzine hydrochloride in each Tablet;Dis the concentration,in µg per mL,of hydroxyzine hydrochloride in theAssay preparationon the basis of the labeled quantity in each Tablet and the extent of dilution;Cis the concentration,in µg per mL,of USP Hydroxyzine Hydrochloride RSin theStandard preparation;andrUandrSare the peak responses obtained from theAssay preparationand theStandard preparation,respectively.
Auxiliary Information— Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 982
Pharmacopeial Forum:Volume No.30(2)Page 507
Phone Number:1-301-816-8165