Glyburide Tablets
»Glyburide Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of glyburide (C23H28ClN3O5S).
Packaging and storage— Preserve in well-closed containers.Store at controlled room temperature.
Identification,Infrared Absorption á197Kñ Prepare the test specimen as follows.Grind to a fine powder a number of Tablets,equivalent to about 15mg of glyburide,add 30mLof acetonitrile,and shake.Filter the mixture,evaporate the filtrate to dryness,and dry the residue in vacuum at 60for 3hours.
Assay—
Mobile phase— Prepare as directed in the Assayfor Glyburide.
System suitability preparation— Prepare a solution of progesterone in acetonitrile having a known concentration of about 0.2mg per mL(Solution A).Transfer about 10mg of USP Glyburide RS,accurately weighed,to a suitable container,add 20.0mLof Solution A,and shake vigorously to dissolve.Add 4.0mLof water,and mix.
Standard preparation— To about 10mg of USP Glyburide RS,accurately weighed,add 20.0mLof acetonitrile,and shake vigorously to dissolve.Add 4.0mLof water,and mix.
Assay preparation— Transfer not fewer than 20Tablets to a suitable container,add water equivalent to 0.4mLof water per mg of glyburide,and swirl to disperse and wet Tablet material.Then add acetonitrile equivalent to 2.0mLof acetonitrile per mg of glyburide,and shake for 30minutes.Centrifuge a portion of the suspension so obtained,and use the clear supernatant.
Chromatographic system— Proceed as directed in the Assayfor Glyburide,except to use the System suitability preparationin place of the Standard preparation.
Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the height of the major peaks.Calculate the quantity,in mg,of glyburide (C23H28ClN3O5S)in the portion of Tablets taken by the formula:
WS(rU/rS),
in which WSis the weight,in mg,of USP Glyburide RStaken to prepare the Standard preparation;and rUand rSare the glyburide peak heights obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 911
Pharmacopeial Forum:Volume No.29(2)Page 418
Phone Number:1-301-816-8251