1.0 OBJECTIVE
To provide the procedure
for Estimation of loratadine tablets (10mg) formulation.
2.0 SCOPE
This procedure is Applicable to the Estimation of loratadine tablets (10mg) formulation.
3.0 RESPONSIBILITY
3.1 QC-Chemist
4.0 ACCOUNTABILITY
4.1 Executive – Quality control
4.2 Head – Quality control
5.0 PROCEDURE
Each Uncoated tablet contains:
Loratadine IP 10mg
5.2 Assay Method:
5.2.1 Standard solution:
Accurately weigh about 10mg of loratadine working standard
and transfer it into 50ml of volumetric flask, add 50 ml of 0.1M methanolic Hcl,
shake well until the material gets dissolved and make up to 100ml with above
solution.
Transfer 1ml of the above solution into 10 ml with 0.1M methanolic
Hcl.
5.2.2 Sample solution:
Weigh and powder 20 tablets. Weigh accurately the tablets
powder equivalent to about 10mg of loratadine into 50ml of
volumetric flask, add 10ml of 0.1M methanolic Hcl, shake well until
dissolve the substance or Sonicate for 3 minutes, make up to volume with 0.1M
methanolic Hcl.
Filter the sample Solution with whatman filter paper No. 41
and reject first few ml of the filtrate.
Transfer 1ml of the above solution into 10 ml with 0.1M methanolic
Hcl.
Measure the absorbance at about 275nm using 0.1M methanolic Hcl as
blank
5.2.3 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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