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

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 Chemistry

E.I. Savelyev


Samples provided by: Envenom Pharm.
  Purpose of the study: Identification and determination of the active principle in the sample prepa-
 Rata "Ibutamoren."
  Object of study: dosage form - capsules.
  Component to be Detected: R-1 '- (2-methyl-alamyl-O-benzyl-D-seryl) -1- (methylsulfonyl) -1,2-
 dihydrospiro [indole-3,4'-piperidine].
  Determination of the active principle in a sample of the drug by the HPLC-UV method.
 Figure 1 and Table 1 present the results of a study of a sample solution of a preparation by the method


  Figure 1 - HPLC-UV - chromatogram of a solution of a sample of the drug "Ibutamoren".
 Table 1 - Characterization of Peaks Presented on HPLC-UV - chromatogram of a sample of a drug


 Chromatographic peak with a retention time of 8.096 minutes. corresponds to R-1 '- (2-methylalamyl-O-
 benzyl-D-seryl) -1- (methylsulfonyl) -1,2-dihydrospiro [indole-3,4'-piperidine]. Chromatographic
 peaks with retention times of 7.770, 8.723, 10.045, 10, 598 correspond to impurity components.
 A quantitative assessment of the main substance was performed by the method of internal normalization. Content
 the active component in the sample of the drug "Ibutamoren" was 94.3%.

  Identification of the main component in the sample of the drug
  HPLC-UV high resolution.

 Figure 2 shows the mass chromatogram and mass spectrum obtained by analyzing the sample solution
 of the drug by HPLC-MS.
 + Identification was performed on the exact mass m/z 529,2479, corresponding to [M + H].


  Figure 2 - HPLC-MS — chromatogram of a solution of a sample of the Ibutamoren preparation.

 Chromatographic peak with a retention time of 11.61 minutes. matches the designated
 connection. Experimentally registered mass 529,24805, deviation from the theoretical
 is 0.3 ppm. Measurement error of the exact mass and elemental composition of the ion (the difference between the measured
 masses from the calculated) & lt; 5 ppm identification is reliable.
 As a result of the research it was found that in the sample submitted to the study
 the main substance is 4- (4-methyl-2- [4- (trifluoromethyl) phenyl] -1,3-thiazol-5-yl) methyl] sulfanyl-
 2-methylphenoxyacetic acid. Estimated content of the analyte in the preparation
 is 98.0%.