Methadone Hydrochloride Tablets
» Methadone Hydrochloride Tablets contain not less than 93.0 percent and not more than 107.0 percent of the labeled amount of methadone hydrochloride (C21H27NO·HCl).
Packaging and storage— Preserve in well-closed containers.
USP Reference standards 11
USP Methadone Hydrochloride RS Click to View Structure
Identification— A quantity of powdered Tablets, equivalent to about 5 mg of methadone hydrochloride, responds to Identification test A under Methadone Hydrochloride Oral Solution.
Dissolution 711
Medium: water; 500 mL.
Apparatus 1: 100 rpm.
Time: 45 minutes.
Procedure— Filter a portion of the solution under test, and pipet a volume of the filtrate, equivalent to about 400 µg of methadone hydrochloride, into a suitable separator. Add 1 mL of glacial acetic acid and 20 mL of a solution of bromocresol purple, prepared by dissolving 200 mg of bromocresol purple in 1000 mL of dilute glacial acetic acid (1 in 50), mix, and extract with 20.0 mL of chloroform. Determine the amount of C21H27NO·HCl dissolved from visible absorbances at the wavelength of maximum absorbance at about 405 nm of the chloroform extract so obtained in comparison with the chloroform extract similarly prepared from a Standard solution having a known concentration of USP Methadone Hydrochloride RS in water.
Tolerances— Not less than 75% (Q) of the labeled amount of C21H27NO·HCl is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Assay—
Mobile phase— Prepare a filtered and degassed mixture of 0.03 M monobasic potassium phosphate and acetonitrile (60:40). Adjust with phosphoric acid to a pH of 3.2. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation— Dissolve an accurately weighed quantity of USP Methadone Hydrochloride RS in Mobile phase to obtain a solution having a known concentration of about 0.4 mg per mL.
Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 10 mg of methadone hydrochloride, to a 25-mL volumetric flask. Add 10 mL of Mobile phase, and sonicate briefly. Shake by mechanical means for 15 minutes, dilute with Mobile phase to volume, mix, and filter.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 254-nm detector and a 3.9-mm × 30-cm column that contains packing L11. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the tailing factor is not more than 2.0, and the relative standard deviation is not more than 2.0%.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of methadone hydrochloride (C21H27NO·HCl) in the portion of Tablets taken by the formula:
25C(rU / rS)
in which C is the concentration, in mg per mL, of USP Methadone Hydrochloride RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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Monograph Clydewyn M. Anthony, Ph.D.
Senior Scientific Liaison
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(SM22010) Monographs - Small Molecules 2
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711 Margareth R.C. Marques, Ph.D.
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(GCDF2010) General Chapters - Dosage Forms
USP35–NF30 Page 3841
Pharmacopeial Forum: Volume No. 28(6) Page 1820