Naltrexone Hydrochloride Tablets
» Naltrexone Hydrochloride Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of naltrexone hydrochloride (C20H23NO4·HCl).
Packaging and storage— Preserve in tight containers.
Identification— The retention time of the major peak for naltrexone 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: water; 900 mL.
Apparatus 2: 50 rpm.
Time: 60 minutes.
Determine the amount of C20H23NO4·HCl dissolved using the method described below.
0.05 M Buffer solution— Dissolve 7.0 g of monobasic sodium phosphate in 1 L of water.
Mobile phase— Prepare a mixture of 600 mL of 0.05 M Buffer solution, 1.1 g of sodium 1-octane sulfonate monohydrate and 400 mL of methanol. Adjust with dilute sodium hydroxide to a pH of 6.7 ± 0.05, if necessary, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 280-nm detector and a 3.9-mm × 15-cm column that contains packing L1 and is heated to 45. The flow rate is about 1 mL per minute. Chromatograph replicate injections of the Standard solution, and record the peak responses as directed for Procedure: the relative standard deviation is not more than 2.0%.
Procedure— Inject a volume (about 100 µL) of a filtered portion of the solution under test into the chromatograph, record the chromatogram, and measure the response for the major peak. Calculate the amount of C20H23NO4·HCl dissolved in comparison with a Standard solution having a known concentration of USP Naltrexone RS in the same Medium and similarly chromatographed.
Tolerances— Not less than 80% (Q) of the labeled amount of C20H23NO4·HCl is dissolved in 60 minutes.
Uniformity of dosage units 905: meet the requirements.
Solution A, Solution B, Mobile phase, Resolution solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Naltrexone Hydrochloride.
Assay preparation— Transfer not fewer than 20 Tablets to a tared container, and determine the average Tablet weight. Grind the Tablets to a homogeneous mixture. Transfer an accurately weighed portion, equivalent to about 250 mg of naltrexone hydrochloride, to a 100-mL volumetric flask. Add about 80 mL of 0.1 M phosphoric acid, and shake or sonicate for at least 30 minutes. Dilute with 0.1 M phosphoric acid to volume, mix, and filter.
Procedure— Proceed as directed for Procedure in the Assay under Naltrexone Hydrochloride. Calculate the quantity, in mg, of naltrexone hydrochloride (C20H23NO4·HCl) in the portion of Tablets taken by the formula:
(377.86/341.40)100C(rU / rS)
in which the terms are defined therein.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3029
Pharmacopeial Forum: Volume No. 29(4) Page 1053
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.