USE OF SPECTRUM METHODS IN DESIGNING STANDARD SAMPLES FOR PEPTIDE DRUGS

Download full text PDF
DOI: https://doi.org/None
Issue: 
1
Year: 
2016

V.I. Gegechkori (1), O.Yu. Shchepochkina (1), PhD;.L.N. Grushevskaya (2), PhD; Prof. B.M. Pyatin (2), PhD; F.S. Baiburtsky (2), PhD 1 -I.M. Sechenov First Moscow State Medical University; 8, Trubetskaya St., Build. 2, Moscow 119991 2 -V.V. Zakusov Research Institute of Pharmacology, Russian Academy of Sciences; 8, Baltiyskaya St., Moscow 1255315

The pharmacopeia drug quality cannot be ensured without a proper standardization process that is now accomplished using physical and physicochemical methods for quality control. To ensure the validity, accuracy, and reproducibility of the results of an analysis, it is necessary to use pharmacopoeia standard samples. Manufacturers themselves design standard samples for innovative Russian drugs. Investigations have shown that GB-115 and Dilepta are suitable to design standard samples of peptide drugs. It is advisable to identify standard samples from the description of ultraviolet spectra (absorption minima and maxima and molar absorptivity) and from the concordance of the infrared spectra of the test samples given in Figs. 1-4.
Keywords: 
pharmacopeia standard samples
standardization
peptide drugs
ultraviolet spectrophotometry
infrared spectroscopy
References: 
  1. Seredenin S.B., Voronina T.A., Gudasheva T.A., Ostrovskaya R.U., Rozancev G.G., Bondarenko N.A. Zameshhennye proliltiroziny, obladayushhie psihotropnoy aktivnost`yu. Patent RF №2091390, 1997.
  2. Seredenin S.B., Gudasheva T.A., Zayceva N.I., Kolik L.G., Briling V.K., Konstantinopol`skiy M.A. Zameshhennye triptofansoderzhashhie dipeptidy s holecistokininonegativnoy ili holecistokininopozitivnoy aktivnost`yu. Patent RF №2227144, 2004.
  3. Klumova V.S., Grushevskaya L.N., Avdyunina N.I., Pyatin B.M, Sergeeva M.S., Gaevaya L.M., Dudenkova M.E. Izuchenie fiziko-himicheskih svoystv i razrabotka metodik analiza substancii novogo ori-ginal`nogo anksioliticheskogo sredstva GB-15. Him.-farm. zhurn., 2011; 10: 53–56.
  4. Klumova V.S., Grushevskaya L.N., Avdyunina N.I., Pyatin B.M, Gaevaya L.M., Sergeeva M.S., Dudenkova M.E., Alekseev K.V., Blynskaya E.V., Tihonova N.V., Turchinskaya K.G. Razrabotka metodik ana-liza tverdoy dozirovannoy lekarstven-noy formy GB-15. Him.-farm. zhurn., 2011;12: 27–31.
  5. Prokof`eva V.I., Pyatin B.M, Gusev M.V., Avdyunina N.I., Grushevskaya L.N. Razrabotka metodik analiza i standar-tizaciya substancii dilepta. Vopr. biol., med. i farm. himii, 2009; 2: 38–41.
  6. Klumova V.S., Grushevskaya L.N., Avdyunina N.I., Pyatin B.M., Sergeeva M.S., Ivanov A.I. Analiz substancii novogo anksiolitika. Farmaciya, 2012; 1: 6–8.
  7. Dorofeev V.L., Arzamascev A.P. Standartnye obrazcy dlya farmakopey-nogo analiza. Vopr. biol., med. i farm. himii, 2010; 5: 6–10.
  8. Arzamascev A.P., Dorofeev V.L., Sadchikova N.P. Proekt Obshhih rekomen-daciy po razrabotke, proizvodstvu i raspredeleniyu gosudarstvennyh stan-dartnyh obrazcov lekarstvennyh veshhestv. Vedomosti Nauchnogo centra e`ks-pertizy i gosudarstvennogo kontrolya lekarstvennyh sredstv Minzdrava Rossii, 2000; 3(4): 29–34.
  9. Orlov F.S. Analiz i standartizaciya lekarstvennoy formy s modificirovan-nym vysvobozhdeniem novogo original`-nogo otechestvennogo preparata «Dilept». Dis. kand. farm. nauk. M.: PMGMU im. I.M. Sechenova, 2012; 125.