Benazepril Hydrochloride Tablets
» Benazepril Hydrochloride Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of benazepril hydrochloride (C24H28N2O5·HCl).
Packaging and storage— Preserve in well-closed containers.
Labeling— When more than one Dissolution test is given, the labeling states the test used only if Test 1 is not used.
Identification—
A: Thin-Layer Chromatographic Identification Test 201
Test solution— Finely powder not fewer than 20 Tablets, and transfer an accurately weighed portion of the powder, equivalent to about 50 mg of benazepril hydrochloride, to a 50-mL volumetric flask. Add about 30 mL of methanol, and shake by mechanical means for 15 minutes. Dilute with methanol to volume, mix, and centrifuge. Pass an aliquot of the supernatant through a suitable filter, discarding the first 6 mL of the filtrate.
Application volume: 20 µL.
Developing solvent system: a mixture of ethyl acetate, methanol, and ammonium hydroxide (80:20:15).
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Dissolution 711
test 1—
Medium: water, 500 mL.
Apparatus 2: 50 rpm.
Time: 30 minutes.
Determine the amount of C24H28N2O5·HCl dissolved by employing the following method.
Tetrabutylammonium bromide solution, Mobile phase, System suitability solution, and Chromatographic system— Proceed as directed in the Assay under Benazepril Hydrochloride.
Procedure— Inject about 60 µL, or an amount of a filtered portion of the solution under test, equivalent to about 1.2 µg of benazepril, into the chromatograph. The amount of benazepril injected should not exceed 1.5 µg. Record the chromatogram, and measure the responses for the major peaks. Determine the quantity, in mg, of C24H28N2O5·HCl dissolved in comparison with a Standard solution having a known concentration of USP Benazepril Hydrochloride RS in the same Medium and similarly chromatographed.
Tolerances— Not less than 80% (Q) of the labeled amount of C24H28N2O5·HCl is dissolved in 30 minutes.
test 2— If the product complies with this test, the labeling indicates that the product meets USP Dissolution Test 2.
Medium, Apparatus, and Procedure— Proceed as directed for Test 1.
Time: 45 minutes.
Tolerances— Not less than 70% (Q) of the labeled amount of C24H28N2O5·HCl is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
procedure for content uniformity—
Tetrabutylammonium bromide solution, Mobile phase, System suitability solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay.
Test preparation— Transfer 1 Tablet to a suitable volumetric flask, add a volume of Mobile phase equivalent to about 50% of the volume of the flask, sonicate for 5 minutes, and then shake by mechanical means for not less than 10 minutes. Dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a final concentration of about 0.2 mg per mL, mix, and pass a portion of the solution through a suitable filter, discarding the first 6 mL of the filtrate.
Procedure— Proceed as directed in the Assay, except to inject the Test preparation instead of the Assay preparation. Calculate the quantity, in mg, of benazepril hydrochloride (C24H28N2O5·HCl) in the Tablet taken by the formula:
VDC(rU / rS)
in which V is the volume, in mL, of the initial flask used to prepare the Test preparation; D is the dilution factor in subsequent dilutions of V, if necessary, to prepare the Test preparation; C is the concentration, in mg per mL, of USP Benazepril Hydrochloride RS in the Standard preparation; and rU and rS are the benazepril hydrochloride peak responses obtained from the Test preparation and the Standard preparation, respectively.
Related compounds—
Tetrabutylammonium bromide solution, Mobile phase, System suitability solution, and Chromatographic system— Proceed as directed in the Assay.
Standard solution— Dissolve an accurately weighed quantity of USP Benazepril Related Compound C RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, to obtain a solution having a known concentration of about 0.006 mg per mL.
Test solution— Use the Assay preparation.
Procedure— Separately inject equal volumes (about 80 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the responses of the peaks for benazepril related compound C. Calculate the percentage of benazepril related compound C in the portion of Tablets taken by the formula:
100(CS / CT)(rU / rS)
in which CS is the concentration, in mg per mL, of USP Benazepril Related Compound C RS in the Standard solution; CT is the concentration, in mg per mL, of benazepril hydrochloride in the Test solution; and rU and rS are the peak responses for benazepril related compound C obtained from the Test solution and the Standard solution, respectively: not more than 3.0% of benazepril related compound C is found. Calculate the percentage of each impurity (other than benazepril related compound C) in the portion of Tablets taken by the formula:
100(ri / rs)
in which ri is the peak response for each impurity obtained from the Test solution; and rs is the sum of the responses of all the peaks (including benazepril related compound C): not more than 1.0% of any individual impurity is found; and not more than 2.0% of total impurities is found, the results for all impurities (excluding benazepril related compound C) being added.
Assay—
Tetrabutylammonium bromide solution, Mobile phase, System suitability solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Benazepril Hydrochloride.
Assay preparation— Finely powder not fewer than 20 Tablets, and transfer an accurately weighed portion of the powder, equivalent to about 50 mg of benazepril hydrochloride, to a 250-mL volumetric flask. Add about 150 mL of Mobile phase, and shake by mechanical means for 30 minutes. Dilute with Mobile phase to volume, mix, and centrifuge. Pass an aliquot of the supernatant through a suitable filter, discarding the first 6 mL of the filtrate.
Procedure— Separately inject equal volumes (about 25 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for all the peaks. Calculate the quantity, in mg, of benazepril hydrochloride (C24H28N2 O5·HCl) in the portion of Tablets taken by the formula:
250C(rU / rS)
in which C is the concentration, in mg per mL, of USP Benazepril Hydrochloride RS in the Standard preparation; and rU and rS are the benazepril hydrochloride 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.
Topic/Question Contact Expert Committee
Monograph Sujatha Ramakrishna, Ph.D.
Scientist
1-301-816-8349
(MDCV05) Monograph Development-Cardiovascular
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
1-301-816-8106
(BPC05) Biopharmaceutics05
USP32–NF27 Page 1635
Pharmacopeial Forum: Volume No. 33(4) Page 637
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.