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Conclusion on the results of the study sample of the drug "Andarin".

Head of the Laboratory of Chemical Analytical Control and Biotesting of the Federal State Unitary Enterprise Scientific Research Institute of Hygiene, Professional Pathologies and Human Ecology of the Federal Medical-Biological Agency, Doctor of Chemical Sciences

E.I. Savelyev


Samples provided by: Envenom Pharm.
  Purpose of the study: Identification and determination of the active principle in the sample prepa-
 “Andarin” army.
  Object of study: dosage form - capsules.
  Component Detected : S-3- (4-acetylaminophenoxy) -2-hydroxy-2-methyl-N- (4-nitro-3-
 trifluoromethylphenyl) propionamide.
  Date of receipt of the sample for research: 04/06/2016
  Research Method: High performance liquid chromatography with mass selective detection -
 in high resolution mode.
  Measurement Tools: Acella Liquid Chromatograph with Mass Spectrometry Detector - LTQ
 Orbitrap Velos with electrospray ionization at atmospheric pressure and software
 Xcalibur data management and processing software.
  Measurement Method: S-3- (4-acetylaminophenoxy) -2-hydroxy-2-methyl-N- (4-nitro-3-
 trifluoromethylphenyl) propionamide in the sample was performed by the method of high-performance liquid
 chromatography with mass selective detection in high resolution mode. Separation
 components of the sample was carried out on a chromatographic column of a liquid chromatograph with a direct
 the detection of separated components by a mass spectrometric detector.
 Brief description of the sample submitted for analysis.
  Trade name of the drug: Andarine. Dosage form - capsules. Active ingredient
 is a substance with the chemical name S-3- (4-acetylaminophenoxy) -2-hydroxy-2-methyl-N- (4-
 nitro-3-trifluoromethylphenyl) propionamide.
  Gross formula: С19Н18F3N3O6
  Molecular Weight: 441.1142 g/mol
  Appearance of the preparation: powder in a black and red capsule.
 The structural formula of the active component:


  Sample preparation for analysis.
 A sample of a 10 mg sample was dissolved in 1 ml of water. For a VYGH-MS analysis, the prepared solution
 diluted 100-fold with deionized water.
  Chromatographic Separation Conditions.
 Chromatography column - Zorbax SB-C8, 150 mm long, 4.6 mm in diameter, particle size
 1.8 micron sorbent.
 Mobile Phase:
 - component A - 0.1% solution of formic acid in deionized water;
 - component B - acetonitrile of the category “for gradient VYHH”;
  The ratio of the components of the mobile phase

 The eluent flow rate is 0.4 ml/min;
 Column thermostat temperature: 35 ° С;
 The volume of sample injected for analysis of 5 µl.
  Operating conditions for a mass spectrometric detector.
 Mass spectrometry detector - LTQ Orbitrap Velos with electrospray ionization at
 atmospheric pressure and Xcalibur data management and processing software.
 - Gas flow desiccant 45 cu
 - Auxiliary Gas Flow $ 15
 –The temperature of the gas-drying 300 ° C;
 –Auxiliary flow temperature 380 ° С;
 - The voltage on the capillary 3500V;
 –Detecting in Full Ion Flow Scan Mode (SCAN): Ion Registration in
 m/z range from 50 to 1000 throughout the analysis (with positive ionization).
 The main component was detected by m/z 442.1221, which corresponds positively
 + charged protonated molecular ion [M + H] S-3- (4-acetylaminophenoxy) -2-hydroxy-2-
 methyl-N- (4-nitro-3-trifluoromethylphenyl) propionamide.


  Figure 1 - HPLC-MS - chromatogram of the solution solution of the sample "Andarin"
  and the mass spectrum of the main component.

 Chromatographic peak with a retention time of 14.54 minutes corresponds to the active substance
 drug "Andarin" with a mass number of m/z 442,1221. Deviation from the theoretical is 0.57
 ppm Measurement error of the exact mass and elemental composition of the ion (the difference between the measured mass and
 calculated) & lt; 5ppm, identification is authentic.
 A chromatographic peak with a retention time of 13.02 minutes corresponds to an impurity component.
 A quantitative assessment of the main substance was performed by the method of internal normalization. Content
 active ingredient in the sample of the drug "Andarin" was 96.8%.
 As a result of the study it was found that in the presented sample of the drug
 "Andarin" the main substance is S-3- (4-acetylaminophenoxy) -2-hydroxy-2-methyl-N- (4-nitro-  3-trifluoromethylphenyl) propionamide. The estimated content of the analyte in prepa