(bue spye' rone hye'' droe klor' ide).
8-Azaspiro[4,5]decane-7,9-dione, 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-, monohydrochloride;
N-[4-[4-(2-Pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride [33386-08-2; 36505-84-7].
Buspirone Hydrochloride contains NLT 97.5% and NMT 102.5% of C21H31N5O2·HCl, calculated on the as-is basis.
• B. The relative retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
• C. Identification TestsGeneral, Chloride 191: Meets the requirements
Sample solution: 10 mg/mL in water
Buffer: 1.36 g/L of monobasic potassium phosphate in water. Adjust the solution with 10% sodium hydroxide (w/v) to a pH of 7.5, and filter.
Mobile phase: Acetonitrile and Buffer (2:3)
Internal standard stock solution: 2.5 mg/mL of propylparaben in methanol
Internal standard solution: 0.125 mg/mL of propylparaben from the Internal standard stock solution in water
Standard stock solution: Dissolve 50 mg of USP Buspirone Hydrochloride RS in 25 mL of 1 N hydrochloric acid in a 100-mL volumetric flask, and dilute with water to volume.
Standard solution: To 10.0 mL of Standard stock solution in a 50.0-mL volumetric flask add 10.0 mL of Internal standard solution, and dilute with water to volume.
Sample stock solution: Dissolve 50 mg of Buspirone Hydrochloride in 25 mL of 1 N hydrochloric acid in a 100-mL volumetric flask, and dilute with water to volume.
Sample solution: 0.1 mg/mL of Buspirone Hydrochloride from the Sample stock solution and 0.025 mg/mL of propylparaben from the Internal standard solution in water
Detector: UV 254 nm
Column: 3.9-mm × 30-cm; packing L1
Flow rate: 2 mL/min
Injection size: 25 µL
Sample: Standard solution
[NoteThe relative retention times for propylparaben and buspirone hydrochloride are about 0.55 and 1.0, respectively. ]
Resolution: NLT 4 between buspirone hydrochloride and the internal standard
Relative standard deviation: NMT 2.0%
Samples: Standard solution and Sample solution
Calculate the percentage of C21H31N5O2·HCl in the portion of Buspirone Hydrochloride taken:
Result = (RU/RS) × (CS/CU) × 100
Acceptance criteria: 97.5%102.5% on the as-is basis
• Water Determination, Method I 921: NMT 0.5%
• Packaging and Storage: Preserve in tight, light-resistant containers, at controlled room temperature.
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2408Pharmacopeial Forum: Volume No. 36(1) Page 74