Procainamide Hydrochloride Extended-Release Tablets
» Procainamide Hydrochloride Extended-Release Tablets contain not less than 93.0 percent and not more than 107.0 percent of the labeled amount of procainamide hydrochloride (C13H21N3O·HCl).
Packaging and storage
Preserve in tight containers.
Labeling
The labeling indicates the Dissolution Test with which the product complies.
Identification
It responds to the Thin-Layer Chromatographic Identification Test 201, 5 µL of the stock solution prepared as directed for Assay preparation in the Assay and 5 µL of the Stock standard solution being applied to the plate, and a solvent system consisting of a mixture of ether, methanol, and ammonium hydroxide (25:5:1) being used to develop the chromatogram.
Dissolution 711
test 1
If the product complies with this test, the labeling indicates that the product meets USP Dissolution Test 1.
Medium:
0.1 N hydrochloric acid; 900 mL.
Apparatus 2:
50 rpm.
Times:
1, 4, and 6 hours.
Procedure
Determine the amount of C13H21N3O·HCl dissolved from UV absorbances at the wavelength of maximum absorbance at about 224 nm, using filtered portions of the solution under test, diluted with Medium, if necessary, in comparison with a Standard solution having a known concentration of USP Procainamide Hydrochloride RS in the same Medium.
Tolerances
The percentage of the labeled amount of C13H21N3O·HCl dissolved at the times specified conforms to Acceptance Table 2.
test 2
If the product complies with this test, the labeling indicates that the product meets USP Dissolution Test 2.
Medium
Proceed as directed for Method B under Delayed-Release Dosage Forms.
acid stage:
0.1 N hydrochloric acid; 900 mL for 1 hour.
buffer stage:
0.05 M phosphate buffer, pH 7.5; 900 mL (see Buffer Solutions under Reagents, Indicators, and Solutions) for not less than 8 hours.
Apparatus 2:
50 rpm, with sinkers.
Times:
1, 4, and 8 hours.
Procedure
Proceed as directed for Procedure in Test 1.
Tolerances
The percentages of the labeled amount of C13H21N3O·HCl dissolved at the times specified conform to Acceptance Table 2.
test 3
If the product complies with this test, the labeling indicates that the product meets USP Dissolution Test 3.
Medium
Proceed as directed under Test 2.
Apparatus 2:
50 rpm, with sinkers.
Times:
1, 3, 6, and 8 hours.
Procedure
Proceed as directed for Procedure in Test 1.
Tolerances
The percentages of the labeled amount of C13H21N3O·HCl dissolved at the times specified conform to Acceptance Table 2.
test 4
If the product complies with this test, the labeling indicates that the product meets USP Dissolution Test 4.
Medium:
0.1 N hydrochloric acid; 900 mL.
Apparatus 1:
50 rpm.
Times:
1, 2, 4, 8, and 14 hours.
Procedure
Proceed as directed for Procedure in Test 1.
Tolerances
The percentages of the labeled amount of C13H21N3O·HCl dissolved at the times specified conform to Acceptance Table 2.
test 5
If the product complies with this test the labeling indicates that the product meets USP Dissolution Test 5.
Medium
Proceed as directed for Method B under Delayed-Release Dosage Forms.
acid stage:
0.1 N hydrochloric acid; 1000 mL for 1 hour.
buffer stage:
0.05 M phosphate buffer, pH 7.5; 1000 mL (see Buffer Solutions under Reagents, Indicators, and Solutions) for not less than 8 hours.
Apparatus 2:
50 rpm, with sinkers.
Times:
1, 4, 6, and 8 hours.
Procedure
Proceed as directed for Procedure in Test 1.
Tolerances
Proceed as directed for Tolerances in Test 2.
for 500 mg tablets
for 750 and 1000 mg tablets
test 6
If the product complies with this test, the labeling indicates that the product meets USP Dissolution Test 6.
Medium
Proceed as directed for Test 2.
Apparatus 2:
50 rpm.
Times:
1, 4, and 8 hours.
Procedure
Proceed as directed for Procedure in Test 1.
Tolerances
Proceed as directed for Tolerances in Test 2.
for 250 mg tablets
for 500 mg tablets
for 750 mg tablets
test 8
If the product complies with this test, the labeling indicates that the product meets USP Dissolution Test 8.
Medium
Proceed as directed for Method B under Delayed-Release Dosage Forms.
acid stage:
0.1 N hydrochloric acid; 900 mL for 1 hour.
buffer stage:
0.05 M phosphate buffer, pH 7.5; 900 mL (see Buffer Solutions under Reagents, Indicators, and Solutions) for not less than 8 hours.
Apparatus 2:
50 rpm, with sinkers.
Times:
1, 4, 6, and 8 hours.
Procedure
Proceed as directed for Procedure in Test 1.
Tolerances
Proceed as directed for Tolerances in Test 2.
Uniformity of dosage units 905:
meet the requirements.
Assay
Mobile phase
Prepare a suitable mixture of water, methanol, and triethylamine (140:60:1), adjust with phosphoric acid to a pH of 7.5, filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation
Dissolve an accurately weighed quantity of USP Procainamide Hydrochloride RS in Mobile phase to obtain a solution having a known concentration of about 0.5 mg per mL (Stock standard solution). Quantitatively dilute an accurately measured volume of this solution with Mobile phase to obtain a solution having a known concentration of about 0.05 mg per mL (Standard preparation).
Assay preparation
Transfer not fewer than 10 Tablets, accurately counted, to a 1000-mL volumetric flask, and add 100 mL of a mixture of methanol and methylene chloride (1:1). Place the flask in a 40 sonicator bath, and sonicate, with occasional shaking, until the Tablets have disintegrated completely. Add about 700 mL of methanol, and sonicate for 10 minutes, with occasional shaking. Allow to cool, dilute with methanol to volume, and mix. Filter a portion of this solution, discarding the first 10 mL of the filtrate. Quantitatively dilute an accurately measured volume of the filtrate with Mobile phase to obtain a solution having a concentration of about 0.5 mg of procainamide hydrochloride per mL. Use a portion of this stock solution for the Identification test. Quantitatively dilute another accurately measured volume of the stock solution with Mobile phase to obtain a solution having a concentration of about 0.05 mg per mL (Assay preparation).
Resolution solution
Prepare a solution of p-aminobenzoic acid in Mobile phase containing 0.1 mg per mL. Pipet 10 mL of this solution and 10 mL of the Stock standard into a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Chromatographic system (see Chromatography 621)
The liquid chromatograph is equipped with a 280-nm detector and a 3.9-mm × 30-cm column that contains 10-µm packing L1. The flow rate is about 1 mL per minute. Chromatograph the Resolution solution: the resolution, R, is not less than 2.0. Chromatograph replicate injections of the Standard preparation: the relative standard deviation is not more than 2.0%.
Procedure
Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. The relative retention times are about 0.5 for p-aminobenzoic acid and 1.0 for procainamide. Calculate the quantity, in mg, of procainamide hydrochloride (C13H21N3O·HCl) per Tablet taken by the formula:
(L / D)(C)(rU / rS)
in which L is the labeled quantity, in mg, of procainamide hydrochloride in each Tablet; D is the concentration, in mg per mL, of procainamide hydrochloride in the Assay preparation, based on the number of Tablets taken, the labeled quantity per Tablet, and the extent of dilution; C is the concentration, in mg per mL, of USP Procainamide Hydrochloride RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 3389
Pharmacopeial Forum: Volume No. 31(1) Page 178
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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