Medium: 0.1 N hydrochloric acid;
900 mL
Apparatus
2 ( Paddle
Appratus ) : 50 rpm
Time: 30 min
Determine
the amount of lisinopril dissolved by using the following method.
Standard
solution:
Lisinopril ws in Medium ( Weigh
accurately about 110 mg of Lisinopril Dihydrate equ. To 100 mg of Lisinopril
and transfer it into 100 ml volumetric flask add 60 ml 0.1 M Hydrochloric
acid dissolved and make up volume to 100 ml with 0.1 M Hydrochloric acid,
Further Dilute 1 ml to 100 ml with medium to make final concentration of
Standard solution 10 mcg/ml)
Sample
solution: Inject a
volume of a filtered portion of the Sample solution into the chromatograph,
record the chromatogram, and measure the response for the major peak.
Mobile
phase and Chromatographic system: Prepare as directed in the Assay.
Determine
the amount of lisinopril dissolved by one of the following procedures.
Analysis
1
Procedure
for a pooled sample: Combine equal volumes of the filtered solutions of the 6 or 12
individual specimens withdrawn, and use the pooled sample as the Sample
solution. Inject a volume of the pooled sample into the chromatograph, record
the chromatogram, and measure the response for the major peak.
Calculate
the quantity of C21H31N3O5
dissolved in comparison with a Standard solution having a known concentration
of Lisinopril ws in the same Medium and similarly chromatographed.
Tolerances
1:
NLT 80% (Q) of the labeled amount of C21H31N3O5
is dissolved:
the
requirements are met if the quantities of active ingredient dissolved from the
pooled sample conform to the accompanying Acceptance Table for a Pooled Sample.
Continue testing through the three stages unless the results conform at either
S1 or S2. The quantity, Q, is the amount of dissolved active ingredient
specified, expressed as a percentage of the labeled content.
Acceptance
Table for a Pooled Sample
|
Stage
|
Number
Tested
|
Acceptance
Criteria
|
|
S1
|
6
|
Average
amount dissolved is NLT Q + 10%.
|
|
S2
|
6
|
Average
amount dissolved (S1 + S2) is equal to or greater than Q + 5%.
|
|
S3
|
12
|
Average
amount dissolved (S1 + S2 + S3) is equal to or greater than Q.
|
Analysis
2
Procedure
for unit sample: Proceed as directed for Apparatus 1 and Apparatus 2,
Immediate-Release Dosage Forms under Dissolution Procedure. Inject a volume of
a filtered portion of the Sample solution into the chromatograph, record the
chromatogram, and measure the response for the major peak.
Calculate
the amount of C21H31N3O5 dissolved
in comparison with the Standard solution having a known concentration of
Lisinopril ws in the Medium and similarly chromatographed.
Std Area Wt.of Std (mg)
1 900 Std Potency
%
=-----------------x---------------------x------x------------x-----------------x100
Spl Area 100 100 10 100
Tolerances
2: NLT 80%
(Q) of the labeled amount of C21H31N3O5 is
dissolved
