A: Infrared Absorption á197Kñ—

Test specimen— Grind 20Tablets to a fine powder,add 50mLof chloroform,stir for 3to 5minutes,and filter into a 250-mLevaporating flask.Evaporate the solution with the aid of a rotary evaporator to dryness at low heat.Use the residue.

B: The relative retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.

Medium: 0.01Nhydrochloric acid;500mL.

Apparatus 2: 50rpm.

Time: 30minutes.

Procedure— Determine the amount of C21H31N5O2.HCl dissolved by employing UVabsorption at the wavelength of maximum absorbances at about 235nm on filtered portions of the solution under test,suitably diluted with 0.01Nhydrochloric acid,in comparison with a Standard solution having a known concentration of USP Buspirone Hydrochloride RSin the same Medium.

Tolerances— Not less than 80%(Q)of the labeled amount of C21H31N5O2.HCl is dissolved in 30minutes.

Buffer solution ,Mobile phase,Standard stock solution,Internal standard solution,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder Buspirone Hydrochloride.

Assay preparation— Transfer a number of Tablets,equivalent to about 100mg of buspirone hydrochloride,to a 200-mLvolumetric flask,add 50mLof 1Nhydrochloric acid,and shake for 15minutes.Add about 100mLof water,and shake for 30minutes.Dilute with water to volume,mix,and filter,discarding the first 20mLof the filtrate.Pipet 10.0mLof the filtrate and 10.0mLof Internal standard solutioninto a 50-mLvolumetric flask,dilute with water to volume,and mix.

Procedure— Proceed as directed for Procedurein the Assayunder Buspirone Hydrochloride.Calculate the quantity,in mg,of buspirone hydrochloride (C21H31N5O2·HCl)in the Tablets taken by the formula: in which Lis the labeled amount,in mg,of buspirone hydrochloride in each Tablet;Dis the concentration,in mg per mL,of buspirone hydrochloride in the Assay preparation,based on the labeled quantity per Tablet and the extent of dilution;Cis the concentration,in mg per mL,of USP Buspirone Hydrochloride RSin the Standard preparation;and RUand RSare the peak response ratios of buspirone hydrochloride to propylparaben obtained from the Assay preparationand the Standard preparation,respectively.