Pregabalin

White Crystalline powder, Slightly hygroscopic. On dried basis, It contains 98.0% to 102.0% of Pregabalin.

Chemical Formula:

C8H17NO2

Chemical Structure

Pregabalin
Pregabalin

SOLUBILITY 

  • Soluble in Water
  • Slightly Soluble in Methanol
  • Very slightly soluble in ethanol
  • Practically insoluble in acetone, ethyl acetate, heptane and in methylene chloride

IDENTIFICATION BY FTIR SPECTROPHOTOMETER

Measure the FTIR spectra of sample and compare with standard.

IDENTIFICATION BY HPLC

The retention time of peak of Pregabalin in sample solution is similar to the retention time of peak of pregabalin in standard solution

APPEARANCE OF SOLUTION

Dissolve 0.5 grams in CO2 Free water and dilute 20ml with same solvent (solution S)

The solution is clear and not more intensely colored than GY5

WATER CONTENTS

NMT 0.5%, determined on 0.200 gram

QUANTITATIVE ASSAY BY HPLC

  • Mobile Phase:

Mix 75 volumes of methanol and 25 volumes of a 6.805 grams/liter solution of potassium dihydrogen phosphate previously adjusted to pH 6.8.

  • Standard solution:

Dissolve 100 mg of pregabalin CRS in the mobile phase and dilute to 100ml with same solvent

  • Sample Solution:

Dissolve 100 mg of substance to examind in the mobile phase and dilute to 100ml with same solvent

 

CHROMATOGRAPHIC SYSTEM

  • Mode    :   LC 100
  • Detector   :   UV 210 nm
  • Column   :   A stainless steel column 0.25 m ­x 4.6mm x 5 µm C18 packing; Octadecylsilanized silica gel (5µm particle diameter).
  • Column temperature :  Ambient
  • Flow rate   :   35 ml/min
  • CHROMATOGRAPHIC PROCEDURE

  • Inject 10µl of mobile phase (blank) and record the chromatograph
  • Inject 10µl of standard solution two times and record the chromatograph
  • Inject 10µl of sample solution and record the chromatograph
  • Inject 10µl of standard solution and record the chromatograph
  • Inject 10µl of mobile phase (blank) and record the chromatograph

CALCULATIONS

Calculate the Percentage of Pregabalin sample by using following formula 

%age Assay = (At/As)× (Cs/Ct) × P

Where

At = Av. Area of the peaks in sample chromatograms

As = Av. Area of the peaks in standard chromatograms

Cs = Concentration (mg/ml) of standard

Ct = Concentration (mg/ml) of sample

P   =  Potency of reference standard

 

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