Lisinopril Tablet Identification Using Silica Gel G TLC Plates

By: Sanjay Poman, Life Science Application Centre (GAC), Mumbai, India,

Introduction

Lisinopril is a drug of the angiotensin converting enzyme (ACE) inhibitor class. It is primarily used in the treatment of high blood pressure, heart failure, and after heart attacks.

With this application note we elaborate how Merck Silica Gel G plates, together with appropriate solvents, reagents and standards can be used for Lisinopril identification testing in tablet formulations.

Lisinopril
Lisinopril
(2S)-1-[(2S)-6-Amino-2-{[(1S)-1-carboxy-3-phenylpropyl]amino}hexanoyl]-2-pyrrolidinecarboxylic acid

 

Experimental Conditions
TLC Plate Silica Gel 60G F254  20x20 cm  
Injection Volume 20 µL
Detection Spray with 0.2% w/v ninhydrine in absolute ethanol
Mobile Phase Glacial acetic acid:butanol:ethyl acetate:water 1:1:1:1 (v/v/v/v) 
Plate development Prewash the plate in methanol and allow to dry in air before use. Use mobile phase described above. Spot standard and sample. Develop the plate for 15 cm. Remove the plate dry in air, spray with 0.2% ninhydrin in ethanol and heat at 105˚C for 10 minutes and examine in day light.
Development Over 2/3rd of the plate
Diluent Water : Methanol ( 2:8 )
Drying In air
Standard Dissolve 0.11% (w/v) of Lisinopril dihydrate in diluent
Sample Shake a quantity of the powdered tablets containing the equivalent of 10 mg of anhydrous lisinopril in diluent.

TLC Plate After Development

TLC Plate After Development
 

 

Chromatogram

Chromatogram

 

Chromatographic Data (Standard Solution)

Chromatographic Data (Standard Solution)

Peak Compound Rf
1 Lisinopril 0.47

 

 

Chromatographic Data (Sample Solution)

Chromatographic Data (Sample Solution)

Peak Compound Rf
1 Lisinopril 0.50

 

 

Standard Repeatability
STD 1 100709
STD 2 103525
STD 3 101176
STD 4 100918
STD 5 103590
Mean 101983
Standard Deviation 1446
RSD (%) 1.4

Conclusions

  • The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution.
     
  • The reference solution repeatability is better than 1.5 %.
     
  • Merck silica gel G plates can be used for the Lisinopril identification test, using butanol, ethyl acetate, glacial acetic acid and water as solvents, and other listed products also comply to set requirements.

Materials

     
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