Buspirone Hydrochloride Tablets
» Buspirone Hydrochloride Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of buspirone hydrochloride (C21H31 N5O2·HCl).
Packaging and storage— Preserve in tight, light-resistant containers, at controlled room temperature.
Test specimen— Grind 20 Tablets to a fine powder, add 50 mL of chloroform, stir for 3 to 5 minutes, and filter into a 250-mL evaporating 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 preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Dissolution 711
Medium: 0.01 N hydrochloric acid; 500 mL.
Apparatus 2: 50 rpm.
Time: 30 minutes.
Procedure— Determine the amount of C21H31N5O2.HCl dissolved by employing UV absorption at the wavelength of maximum absorbances at about 235 nm on filtered portions of the solution under test, suitably diluted with 0.01 N hydrochloric acid, in comparison with a Standard solution having a known concentration of USP Buspirone Hydrochloride RS in the same Medium.
Tolerances— Not less than 80% (Q) of the labeled amount of C21H31N5O2.HCl is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Buffer solution, Mobile phase, Internal standard solution, Standard stock solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Buspirone Hydrochloride.
Assay preparation— Transfer a number of Tablets, equivalent to about 100 mg of buspirone hydrochloride, to a 200-mL volumetric flask, add 50 mL of 1 N hydrochloric acid, and shake for 15 minutes. Add about 100 mL of water, and shake for 30 minutes. Dilute with water to volume, mix, and filter, discarding the first 20 mL of the filtrate. Pipet 10.0 mL of the filtrate and 10.0 mL of Internal standard solution into a 50-mL volumetric flask, dilute with water to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Buspirone Hydrochloride. Calculate the quantity, in mg, of buspirone hydrochloride (C21H31N5O2·HCl) in the Tablets taken by the formula:
(L / D)C(RU / RS)
in which L is the labeled amount, in mg, of buspirone hydrochloride in each Tablet; D is 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; C is the concentration, in mg per mL, of USP Buspirone Hydrochloride RS in the Standard preparation; and RU and RS are the peak response ratios of buspirone hydrochloride to propylparaben obtained from the Assay preparation and the Standard preparation, respectively.
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Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
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Senior Scientist
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USP32–NF27 Page 1726
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.