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 C
20H
23NO
4·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.
Assay
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 (C
20H
23NO
4·HCl) in the portion of Tablets taken by the formula:
(377.86/341.40)100C(rU / rS),
in which the terms are defined therein.