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

For the treatment of premature ejaculation
Store at +4°C. Store under desiccating conditions. The product can be stored for up to 12 months.
Sampling
Dapoxtine Visual Appearance Sample solution
The proposed method was successfully applied for the determination of Dapoxetine HCl in tablet dosage form.
Film-coated tablet. Ten tablets were weighed and powdered.
The amount of tablet powder equivalent to 10 mg of Dapoxetine HCl was weighed accurately and transferred to
The 30 mg film-coated tablets are light grey, round, convex, approximately 6.5 mm in diameter and 60 mL methanol and kept for 5 min in sonicator and volume was made up to 100 mL with the same solvent
debossed with “30” inside a triangle on one side. The solution was then filtered through whatmann filter paper # 41. This filtrate was diluted suitably with
methanol to get the solution of 10 μg/mL concentration .
The 60 mg film-coated tablets are grey, round, convex, approximately 8 mm in diameter and debossed The absorbance was measured against blank.
with “60” inside a triangle on one side. 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
tube,and the basket rack is
positioned in a 1-L beaker of
water,simulated gastric fluid . or
simulated intestinal fluid, move
the basket up and down through
a distance of 5-6 cm at frequency
of 28-32 eyeles per minute note
the time required to complete
disappearance of tablet from
glass tube.
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
mg of Dapoxetine HCl in 100 mL of methanol to get 100 μg/mL solution.
Stock solution was further diluted to produce 100 μg/mL.
This solution was further diluted for the preparation of calibration curve
The absorbance of the solutions containing Dapoxetine HCl at 10μg/ml was determined and absorbance maxima
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
Calibration curve was prepared in methanol at λmax 291 nm using Shimadzu UV Visible spectrophotometer
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 Ghoniem Dr. Ommia