1.0 OBJECTIVE
To provide the procedure
for the determination of Diltiazem
hydrochloride tablets (30/90/60/120mg)
2.0 SCOPE
This procedure is
Applicable to the determination of Diltiazem
hydrochloride tablets (30/90/60/120mg)
3.0 RESPONSIBILITY
3.1 QC-Chemist
4.0 ACCOUNTABILITY
4.1 Executive – Quality
control
4.2 Head – Quality
control
5.0 PROCEDURE
5.1 Label Claim:
Each uncoated tablet Contains:
Diltiazem hydrochloride IP ……………….30/90/60/120mg
5.2 Assay Method:
5.2.1 Preparation of
standard solution:
Dissolve 100mg of the Diltiazem hydrochloride in 50ml
of chloroform and further diluted to 100ml with chloroform. Further dilute 10ml
of the above solution into 100ml with chloroform.
5.2.2 Preparation of
Sample solution:
Weight powder twenty
tablets and take the powder equivalent to100mg Diltiazem hydrochloride was accurately weighed, dissolved
in 100 ml of chloroform, filtered through Whatmann filter paper No: 41.
Further dilute 10ml of
the above solution into 100ml with chloroform.
5.2.3 Measure the absorbance at about 249.8 nm
5.2.4 Calculate the content by comparison.
Sample absorbance x Standard weight x
Assay x Average weight of the tablet =
Standard absorbance x Sample Weight
x 100
= ____________x100
LC
LC: Label Claim
6.0 ANNEXURES
Nil
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