Amantadine Hydrochloride Oral Solution
» Amantadine Hydrochloride Oral Solution contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of amantadine hydrochloride (C10H17N·HCl).
Packaging and storage— Preserve in tight containers.
Identification, Infrared Absorption 197S
Cell: 1 mm.
Solution— Place a volume of Oral Solution, equivalent to about 200 mg of amantadine hydrochloride, in a vessel, dissolve in 0.1 N hydrochloric acid, and filter. Transfer the filtrate to a separator, add 10 mL of 0.5 N sodium hydroxide, and extract with 5 mL of methylene chloride. Filter the extract through anhydrous sodium sulfate, and rinse the anhydrous sodium sulfate with 2 mL of methylene chloride.
Internal standard solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Amantadine Hydrochloride Capsules.
Assay preparation— Pipet 5.0 mL of the Oral Solution into a 250-mL conical flask, and add 45 mL of 1.0 N sodium hydroxide and 50.0 mL of Internal standard solution. Shake for 60 minutes, and collect the hexane layer (Assay preparation).
Procedure— Proceed as directed in the Assay under Amantadine Hydrochloride Capsules. Calculate the quantity, in mg, of amantadine hydrochloride (C10H17N·HCl) in the portion of Oral Solution taken by the formula:
50C(RU / RS)
in which C is the concentration, in mg per mL, of USP Amantadine Hydrochloride RS in the Standard preparation; and RU and RS are the peak response ratios obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Behnam Davani, Ph.D., M.B.A.
Senior Scientist
(MDAA05) Monograph Development-Antivirals and Antimicrobials
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 1505
Pharmacopeial Forum: Volume No. 28(2) Page 251
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.