Diclofenac Sodium

DESCRIPTION:

Diclofenac Sodium is white or slightly yellowish, slightly hygroscopic, crystalline powder.

CHEMICAL FORMULA:

C14H10Cl2NNaO2

CHEMICAL STRUCTURE:

Diclofenac Sodium
Diclofenac Sodium

MOLECULAR WEIGHT:

318.1 Dalton

USE AS:

Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.

IUPAC NAME:

Sodium [2-[(2,6-dichlorophenyl)amino]phenyl]acetate.

CONTENTS:

It contains not less than 99.0% and not more than 101.0% of C14H10Cl2NNaO2.

SOLUBILITY:

  • Sparingly soluble in water.
  • Freely soluble in Methanol.
  • Soluble in ethanol.
  • Slightly Soluble in acetone.

MELTING POINT:

Determine the melting point of sample by using M.P instrument. It decomposes at 280°C.

IDENTIFICATION BY FTIR SPECTROPHOTOMETER:

Measure the FTIR spectra of sample and compare with standard.

IDENTIFICATION BY SODIUM REACTION:

Dissolve 60mg in 0.5mL of methanol and add 0.5 mL of water R. The solution gives reaction of sodium.

IDENTIFICATION BY COLOR OF SOLUTION:

Dissolve 1.25 gm in 25 mL methanol. And check its color & measure absorbance at 440 nm its absorbance should not be greater than 0.05

pH:

Dissolve 1.0 gm in Distilled water & dilute to 100ml and determine the pH. It should be in between 7.5 to 9.0.

LOSS ON DRYING:

Take 1.0gm of sample & dry in oven at 105-110oC for 3.0 hours. It should not be greater than 0.5%.

QUANTITATIVE ASSAY: (By Non-Aqueous TITRATION)

Dissolve 450 mg of Diclofenac Sodium in 25mL Glacial acetic acid. Add 2 drops of crystal violet indicator. Titrate with 0.1N Perchloric acid till change in color of indicator. If necessary, carry out blank titration.

Each ml of 0.1N HClO4 is equivalent to 31.81 mg of C14H10Cl2NNaO2.

CALCULATIONS:

Calculate the Percentage of Diclofenac Sodium by using following Expression.

%age assay = ((R x 31.81) /  (W-(100-X)) x 100

Where

R = Reading at Burette (Vol. of 0.1N HClO4)

W = Weight of sample taken

X = Water contents

STORAGE CONDITION:

It should be packed in airtight containers. Containers should not be transparent to light.

REFERENCE:

British Pharmacopia 2016. Volume-I, Page 740

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