Arrangements of Quality Assurance Active Pharmaceutical Ingredient

DapoxetineHcl
1-Dapoxtine Tablets Specific tests:
• Stability :Tablets were packed in aluminium blister pack and charged for Stability study at
Trade Name
accelerated condition 40°C/75% RH) for 2 months in a humidity chamber Durajoi

• Hardness test Chemical Name

• Friability test
dimethyl[(1S)-3-(naphthalen-1-yloxy)-1-phenylpropyl]amine

Dapoxtine storage condition : Storage instructions USES

Dapoxetine is a selective serotonin reuptake inhibitor, for the treatment of premature
Store at +4°C. Store under desiccating conditions. The product can be stored for up to 12 months.
ejaculation.

Dapoxtine Visual Appearance Sampling

Sample solution
Film-coated tablet. The proposed method was successfully applied for the determination of Dapoxetine HCl in tablet dosage form.
Ten tablets were weighed and powdered.
The 30 mg film-coated tablets are light grey, round, convex, approximately 6.5 mm in diameter and The amount of tablet powder equivalent to 10 mg of Dapoxetine HCl was weighed accurately and transferred to
debossed with “30” inside a triangle on one side. 60 mL methanol and kept for 5 min in sonicator and volume was made up to 100 mL with the same solvent
The solution was then filtered through whatmann filter paper # 41. This filtrate was diluted suitably with
The 60 mg film-coated tablets are grey, round, convex, approximately 8 mm in diameter and debossed
methanol to get the solution of 10 μg/mL concentration .
with “60” inside a triangle on one side. The absorbance was measured against blank.
The drug content of the preparation was calculated using standard calibration curve

Procedure for its method of analysis

Hardness test
Erweka tester measures a
tablet put on the bottom anvil
and a load moving along a rail
transfers pressure gradually to
the tablet.
Friability test
Put tablets it into friabilator,
rotate the drum at 25 rpm per
min. During this,tablet gets
dropped on plastic from 6 inches,
it will pass through mechanical
shocks. After 4 minutes. calculate
final weight of tablets ,then %
friability.
Disintegration test
one tablet is placed in each
Drug should be soluble as well as stable for sufficient time in selected media.
reported media for this drug are water, methanol, chloroform, acetonitrile and 0.1 M HCl, but it gives the most
accurate linearity in methanol compared to other solventsstandard Stock solution was prepared by dissloving 100
tube,and the basket rack is
mg of Dapoxetine HCl in 100 mL of methanol to get 100 μg/mL solution.
positioned in a 1-L beaker of
Stock solution was further diluted to produce 100 μg/mL.
water,simulated gastric fluid . or
This solution was further diluted for the preparation of calibration curve
simulated intestinal fluid, move
The absorbance of the solutions containing Dapoxetine HCl at 10μg/ml was determined and absorbance maxima
the basket up and down through
a distance of 5-6 cm at frequency
of Dapoxetine HCl was detected at 210 nm, 230 nm and 291 nm among which 291 nm [Figure 2] was chosen for its
good linearity
of 28-32 eyeles per minute note
Calibration curve was prepared in methanol at λmax 291 nm using Shimadzu UV Visible spectrophotometer
the time required to complete
disappearance of tablet from
glass tube.
References
https://pubchem.ncbi.nlm.nih.gov/compound/Dapoxetine-hydrochloride
https://www.drugbank.ca/drugs/DB04884
http://www.ijddr.in/drug-development/development-and-validation-of-uv-spectrophotometric-method-forestimation-of-
dapoxetine-hcl-in-bulk-and-dosage-form.php?aid=5091

Aisha Mahmoud Sara AbdelAziz Prof.Dr/ Hesham Salem

Sara Khalaf Shimaa Abo Ghanima Dr. Ommia Ali