Chemical and analytical studies necessary for the development and standardization of pharmaceuticals of natural and synthetic origin

development/adoption of techniques for analysis and standardization of single and multicomponent pharmaceuticals of natural and synthetic origin in various medical forms (oil extracts, dry extracts, suppositories, tablets, capsules, syrups, tinctures, etc.);
development/adoption of analytical techniques in dissolution test and study of release of active components in vitro;
validation of analytical techniques;
study of stability of objects in conditions of natural storage and “accelerated” aging;
preparation of draft regulations (Manufacturer monograph, Technical specification) about pharmaceuticals, biologically active additives (BAA), functional nutrition, etc. for pharmaceutical, food and cosmetic industry.

Preparation of draft regulations is carried out according to the following requirements:

State Pharmacopoeia of the Russian Federation, ed. 12, Part 1, M., 2008, 704 pp;
State Pharmacopoeia of the USSR, ed. 11 revised and ext., Part 1, M., 1987, 335 pp; Part 2, M., 1989, 398 pp;
OST 91500.05.001-00 Quality standards of medicines. Basic provisions, M., 2000, 54 pp;

4. Leading foreign pharmacopeias.

Publications by topic:

Pozharitskaya O. N., Kosman V. M., Shikov A. N., Demchenko D. V., Eschenko A. Yu., Makarov V.G. Comparison between HPLC and HPTLC-densitometry for the determination of icariin from Epimedium koreanum extracts// Journal of Separation Science.- 2007, 30(5).- P. 708-712. (DOI 1002/jssc.200600442)
Pozharitskaya O. N., Ivanova S.A., Shikov A. N., Makarov V.G. Separation and evaluation of free radical-scavenging activity of phenol components of Emblica officinalis extract by using an HPTLC-DPPH method // Journal of Separation Science.- 2007, Vol. 30 (9).- P. 1250-1254. (DOI 1002/jssc.200600532)
Pozharitskaya O. N., Ivanova S.A., Shikov A. N., Makarov V.G., Galambosi B. Separation and evaluation of free radical-scavenging activity of phenol components of green, brown and black leaves of Bergenia crassifolia by using HPTLC-DPPH• method. // Journal of Separation Science.- 2007, Vol. 30 (15).- P .2447-2451. (DOI 1002/jssc.200700178)
Urakova I.N., Pozharitskaya O.N., Shikov A.N., Kosman V.M., Makarov V.G. Comparison of high performance TLC and HPLC for separation and quantification of chlorogenic acid in green coffee bean extracts// Journal of Separation Science.- 2008, Vol. 31(2). – P.237-241. (DOI 1002/jssc.200700472)
Pozharitskaya O. N., Ivanova S.A., Shikov A. N., Makarov V.G. Separation and Free Radical-scavenging Activity of Major Curcuminoids of Curcuma longa Using HPTLC-DPPH Method. // Phytochemical Analysis. – 2008, Vol. 19 (4). – P. 236-243 (DOI 1002/pca.1035)
Urakova I.N., Pozharitskaya O.N., Shikov A.N., Kosman V.M., Makarov V.G. Development and validation of a HPLC method for simultaneous determination of ascorbic acid and three phenolic acids in sustained release tablets at single wavelength// Chromatographia.- 2008.- Vol. 67 (9/10).- P. 709-713. (DOI 1365/s10337-008-0576-8)
Poltanov E.A., Shikov A.N., Dorman H.J.D., Pozharitskaya O.N., Makarov V.G., Tikhonov V.P., Hiltunen R. Chemical and Antioxidant Evaluation of Indian Gooseberry (Emblica officinalis, syn. Phyllanthus emblica L.) Supplements// Phytotherapy Research. – 2009, Vol. 23(9).- P.1309-1315 (DOI 10.1002/ptr.2775)
Shikov A.N., Kundracikova M., Palama T.L., Pozharitskaya O.N., Kosman V.M., Makarov V.G., Galambosi B., Kim H. J., Jang Y.P., ChoiH., Verpoorte R. Phenolic consitituents of Gnaphalium uliginosum L.// Phytochemistry letters.- 2010.- Vol. 3(1).-P. 45-47. (DOI 10.1016/j.phytol.2009.11.002)
Shikov A.N., Pozharitskaya O.N., Ivanova S.A., Makarov V.G., Tikhonov V.P., Galambosi B. Improved and Validated HPTLC Method for Quantification of Oenothein B and its Use for Analysis of Epilobium angustifolium // JPC – Journal of Planar Chromatography – Modern TLC.- 2010.- Vol. 23(1).- P. 70-74. (DOI 10.1556/JPC.23.2010.1.12)
Pozharitskaya O.N., Shikov A.N., Makarova M.N., Kosman V.M., Faustova N.M., Tesakova S.V., Makarov V.G., Galamosi B. Anti-inflammatory activity of a HPLC-fingerprinted aqueous infusion of aerial part of Bidens tripartita // Phytomedicine. – 2010.- Vol. 17(6).- P. 463-468. (DOI 10.1016/j.phymed.2009.08.001)
Guseva S. I., Karlina M.V., Pozharitskaya O.N., Shikov A.N., Faustova N.M. Validation of a quantitative determination method of diclofenac for in vitro bioequivalence evaluation of transdermal gel preparations. // Pharmaceutical Chemistry Journal.-2010.-Vol. 44, N 1.- P. 43-46. (DOI 1007/s11094-010-0393-x)
Ioset K.N., Nyberg N.T., Van Diermen D., Malnoe P., Hostettmann K., Shikov A.N., Jaroszewski J.W. Metabolic Profiling of Rhodiola rosea Rhizomes by ¹H NMR Spectroscopy// Phytochemical analysis.- 2011.- Vol. 22 (2).- P. 158-165. (DOI 1002/pca.1262)
Dorman H.J.D., Shikov A.N., Pozharitskaya O.N., Hiltunen R. Antioxidant and Pro-Oxidant Evaluation of a Potentilla alba L. Rhizome Extract.// Chemistry & Biodiversity.- 2011.- Vol. 8 (7).- P.1344-1356. (DOI 1002/cbdv.201100043)
Shikov A.N., Pozharitskaya O.N., Kamenev I.Yu., Makarov V.G. Arznei- und Gewürzpflanzen in Russland.// Zeitschrift für Arznei & Gewürzpflanzen.- 2011.- Vol. 16(3).- P. 135-137. (Web zag-info.de)
Shikov A.N., Ossipov V.I., Martiskainen O., Pozharitskaya N., Ivanova S.A., Makarov V.G. The offline combination of thin-layer chromatography and high-performance liquid chromatography with diode array detection and micrOTOF-Q mass spectrometry for the separation and identification of spinochromes from sea urchin (Strongylocentrotus droebachiensis) shells.// Journal of Chromatography A.- 2011.- Vol. 1218(50).- P. 9111-9114 (DOI 10.1016/j.chroma.2011.10.045)
Demchenko D.V., Pozharitskaya O.N., Shikov A.N., Makarov V.G. Validated HPTLC Method for Quantification of Vitamin D₃ in Fish Oil // JPC – Journal of Planar Chromatography – Modern TLC.- 2011.- Vol. 24(6).- P.487-490. (DOI 1556/JPC.24.2011.6.00)
Fan T.-P., Deal G., Koo H.-L., Rees D., Sun H., Chen S., Dou J.-H., Makarov V.G., Pozharitskaya O.N., Shikov A.N., Kim Y.S., Huang Yi-T., Chang Y.S., Jia W. Dias A., Wong V.C., Chan K. Future development of global regulations of Chinese herbal products.// Journal of Etnopharmacology.- 2012.-Vol. 140(3).- 568-586. (DOI 1016/j.jep.2012.02.029)
Chernetsova E.S., Crawford E.A., Shikov A.N., Pozharitskaya O.N., Makarov V.G., Morlock G.E. ID-CUBE direct analysis in real time high-resolution mass spectrometry and its capabilities in the identification of phenolic components from the green leaves of Bergenia crassifolia// Rapid Communications in Mass Spectrometry.- 2012.- Vol. 26(11).- P. 1329-1337. (DOI 10.1002/rcm.6226).
Kosman V.M., Faustova N.M., Pozharitskaya O.N., Shikov A.N., Makarov V.G. Accumulation of biologically active compounds in underground parts of composition of Potentilla alba after various cultivation terms. Khimija Rastitel’nogo Syr’ja.- 2013.- N 2.- P. 139-146. (DOI 10.14258/jcprm.1302139)
Pozharitskaya O.N., Ivanova S.A., Shikov A.N., Makarov V.G. Evaluation of Free Radical-Scavenging Activity of Sea Urchin Pigments Using HPTLC with Post-chromatographic Derivatization// Chromatoraphia.- 2013.- Vol.76 (19-20).- P.1353-1358 (DOI: 1007/s10337-013-2427-5)
Pozharitskaya O.N., Shikov A.N., Makarova M.N., Ivanova S.A., Kosman V.M., Makarov V.G., Bazgier V., Berka K., Otyepka M., Ulrichová J. Antiallergic effects of pigments isolated from green sea urchin (Strongylocentrotus droebachiensis)// Planta Medica.- 2013.- Vol. 79(18).- P. 1698-1704 (DOI: 10.1055/s-0033-1351098)
Chernetsova, E.S., Shikov, A.N. Crawford, E.A., Grashorn, S., Laakso, I., Pozharitskaya, O.N., Makarov, V.G., Hiltunen, R., Galambosi, B., Morlock, G.E. Characterization of volatile and semi-volatile compounds in green and fermented leaves of Bergenia crassifolia by gas chromatography-mass spectrometry and ID-CUBE direct analysis in real time-highresolution mass spectrometry.// European Journal of Mass Spectrometry. 2014. – Vol. 20(2).- P. 199-205. (DOI: 10.1255/ejms.1252)
Shikov A.N., Pozharitskaya O.N., Makarova M.N., Makarov V.G., Wagner H. Bergenia crassifolia (L.) Fritsch – Pharmacology and phytochemistry.// Phytomedicine.- 2014.- Vol. 21(12).- P. 1534-1542 (DOI: 1016/j.phymed.2014.06.009)
Salminen J.-P., Shikov A.N., Karonen M., Pozharitskaya O.N., Kim J., Makarov V.G., Hiltunen R. Galambosi B. Rapid profiling of phenolic compounds of green and fermented Bergenia crassifolia leaves by UPLC-DAD-QqQMS and HPLC-DAD-ESI-QTOF-MS. // Natural Product Research.- 2014.- Vol. 28(19).- P.1530-1533. (DOI: 10.1080/14786419.2014.923999)
Shikov A.N., Pozharitskaya O.N., Makarova M.N., Makarov V.G., Yang W-Z., Guo D-A. Oplopanax elatus (Nakai) Nakai: chemistry, traditional use and pharmacology// Chinese Journal of Natural Medicines.- 2014.- Vol. 12(10).- P. 721-729. (DOI: 3724/SP.J.1009.2014.00721)
Косман В.М., Крышень К.Л., Крышень А.А., Гаврилин М.В., Пожарицкая О.Н., Макарова М.Н. Валидация теста «Аномальная токсичность» для стандартизации субстанции инсулина // Разработка и регистрация лекарственных средств. -2016, № 3. –С. 78-84.

Pozharitskaya O. N., Kosman V. M., Shikov A. N., Demchenko D. V., Eschenko A. Yu., Makarov V.G. Comparison between HPLC and HPTLC-densitometry for the determination of icariin from Epimedium koreanum extracts// Journal of Separation Science.- 2007, 30(5).- P. 708-712. (DOI 1002/jssc.200600442)
Pozharitskaya O. N., Ivanova S.A., Shikov A. N., Makarov V.G. Separation and evaluation of free radical-scavenging activity of phenol components of Emblica officinalis extract by using an HPTLC-DPPH method // Journal of Separation Science.- 2007, Vol. 30 (9).- P. 1250-1254. (DOI 1002/jssc.200600532)
Pozharitskaya O. N., Ivanova S.A., Shikov A. N., Makarov V.G., Galambosi B. Separation and evaluation of free radical-scavenging activity of phenol components of green, brown and black leaves of Bergenia crassifolia by using HPTLC-DPPH• method. // Journal of Separation Science.- 2007, Vol. 30 (15).- P .2447-2451. (DOI 1002/jssc.200700178)
Urakova I.N., Pozharitskaya O.N., Shikov A.N., Kosman V.M., Makarov V.G. Comparison of high performance TLC and HPLC for separation and quantification of chlorogenic acid in green coffee bean extracts// Journal of Separation Science.- 2008, Vol. 31(2). – P.237-241. (DOI 1002/jssc.200700472)
Pozharitskaya O. N., Ivanova S.A., Shikov A. N., Makarov V.G. Separation and Free Radical-scavenging Activity of Major Curcuminoids of Curcuma longa Using HPTLC-DPPH Method. // Phytochemical Analysis. – 2008, Vol. 19 (4). – P. 236-243 (DOI 1002/pca.1035)
Urakova I.N., Pozharitskaya O.N., Shikov A.N., Kosman V.M., Makarov V.G. Development and validation of a HPLC method for simultaneous determination of ascorbic acid and three phenolic acids in sustained release tablets at single wavelength// Chromatographia.- 2008.- Vol. 67 (9/10).- P. 709-713. (DOI 1365/s10337-008-0576-8)
Poltanov E.A., Shikov A.N., Dorman H.J.D., Pozharitskaya O.N., Makarov V.G., Tikhonov V.P., Hiltunen R. Chemical and Antioxidant Evaluation of Indian Gooseberry (Emblica officinalis, syn. Phyllanthus emblica L.) Supplements// Phytotherapy Research. – 2009, Vol. 23(9).- P.1309-1315 (DOI 10.1002/ptr.2775)
Shikov A.N., Kundracikova M., Palama T.L., Pozharitskaya O.N., Kosman V.M., Makarov V.G., Galambosi B., Kim H. J., Jang Y.P., ChoiH., Verpoorte R. Phenolic consitituents of Gnaphalium uliginosum L.// Phytochemistry letters.- 2010.- Vol. 3(1).-P. 45-47. (DOI 10.1016/j.phytol.2009.11.002)
Shikov A.N., Pozharitskaya O.N., Ivanova S.A., Makarov V.G., Tikhonov V.P., Galambosi B. Improved and Validated HPTLC Method for Quantification of Oenothein B and its Use for Analysis of Epilobium angustifolium // JPC – Journal of Planar Chromatography – Modern TLC.- 2010.- Vol. 23(1).- P. 70-74. (DOI 10.1556/JPC.23.2010.1.12)
Pozharitskaya O.N., Shikov A.N., Makarova M.N., Kosman V.M., Faustova N.M., Tesakova S.V., Makarov V.G., Galamosi B. Anti-inflammatory activity of a HPLC-fingerprinted aqueous infusion of aerial part of Bidens tripartita // Phytomedicine. – 2010.- Vol. 17(6).- P. 463-468. (DOI 10.1016/j.phymed.2009.08.001)
Guseva S. I., Karlina M.V., Pozharitskaya O.N., Shikov A.N., Faustova N.M. Validation of a quantitative determination method of diclofenac for in vitro bioequivalence evaluation of transdermal gel preparations. // Pharmaceutical Chemistry Journal.-2010.-Vol. 44, N 1.- P. 43-46. (DOI 1007/s11094-010-0393-x)
Ioset K.N., Nyberg N.T., Van Diermen D., Malnoe P., Hostettmann K., Shikov A.N., Jaroszewski J.W. Metabolic Profiling of Rhodiola rosea Rhizomes by ¹H NMR Spectroscopy// Phytochemical analysis.- 2011.- Vol. 22 (2).- P. 158-165. (DOI 1002/pca.1262)
Dorman H.J.D., Shikov A.N., Pozharitskaya O.N., Hiltunen R. Antioxidant and Pro-Oxidant Evaluation of a Potentilla alba L. Rhizome Extract.// Chemistry & Biodiversity.- 2011.- Vol. 8 (7).- P.1344-1356. (DOI 1002/cbdv.201100043)
Shikov A.N., Pozharitskaya O.N., Kamenev I.Yu., Makarov V.G. Arznei- und Gewürzpflanzen in Russland.// Zeitschrift für Arznei & Gewürzpflanzen.- 2011.- Vol. 16(3).- P. 135-137. (Web zag-info.de)
Shikov A.N., Ossipov V.I., Martiskainen O., Pozharitskaya N., Ivanova S.A., Makarov V.G. The offline combination of thin-layer chromatography and high-performance liquid chromatography with diode array detection and micrOTOF-Q mass spectrometry for the separation and identification of spinochromes from sea urchin (Strongylocentrotus droebachiensis) shells.// Journal of Chromatography A.- 2011.- Vol. 1218(50).- P. 9111-9114 (DOI 10.1016/j.chroma.2011.10.045)
Demchenko D.V., Pozharitskaya O.N., Shikov A.N., Makarov V.G. Validated HPTLC Method for Quantification of Vitamin D₃ in Fish Oil // JPC – Journal of Planar Chromatography – Modern TLC.- 2011.- Vol. 24(6).- P.487-490. (DOI 1556/JPC.24.2011.6.00)
Fan T.-P., Deal G., Koo H.-L., Rees D., Sun H., Chen S., Dou J.-H., Makarov V.G., Pozharitskaya O.N., Shikov A.N., Kim Y.S., Huang Yi-T., Chang Y.S., Jia W. Dias A., Wong V.C., Chan K. Future development of global regulations of Chinese herbal products.// Journal of Etnopharmacology.- 2012.-Vol. 140(3).- 568-586. (DOI 1016/j.jep.2012.02.029)
Chernetsova E.S., Crawford E.A., Shikov A.N., Pozharitskaya O.N., Makarov V.G., Morlock G.E. ID-CUBE direct analysis in real time high-resolution mass spectrometry and its capabilities in the identification of phenolic components from the green leaves of Bergenia crassifolia// Rapid Communications in Mass Spectrometry.- 2012.- Vol. 26(11).- P. 1329-1337. (DOI 10.1002/rcm.6226).
Kosman V.M., Faustova N.M., Pozharitskaya O.N., Shikov A.N., Makarov V.G. Accumulation of biologically active compounds in underground parts of composition of Potentilla alba after various cultivation terms. Khimija Rastitel’nogo Syr’ja.- 2013.- N 2.- P. 139-146. (DOI 10.14258/jcprm.1302139)
Pozharitskaya O.N., Ivanova S.A., Shikov A.N., Makarov V.G. Evaluation of Free Radical-Scavenging Activity of Sea Urchin Pigments Using HPTLC with Post-chromatographic Derivatization// Chromatoraphia.- 2013.- Vol.76 (19-20).- P.1353-1358 (DOI: 1007/s10337-013-2427-5)
Pozharitskaya O.N., Shikov A.N., Makarova M.N., Ivanova S.A., Kosman V.M., Makarov V.G., Bazgier V., Berka K., Otyepka M., Ulrichová J. Antiallergic effects of pigments isolated from green sea urchin (Strongylocentrotus droebachiensis)// Planta Medica.- 2013.- Vol. 79(18).- P. 1698-1704 (DOI: 10.1055/s-0033-1351098)
Chernetsova, E.S., Shikov, A.N. Crawford, E.A., Grashorn, S., Laakso, I., Pozharitskaya, O.N., Makarov, V.G., Hiltunen, R., Galambosi, B., Morlock, G.E. Characterization of volatile and semi-volatile compounds in green and fermented leaves of Bergenia crassifolia by gas chromatography-mass spectrometry and ID-CUBE direct analysis in real time-highresolution mass spectrometry.// European Journal of Mass Spectrometry. 2014. – Vol. 20(2).- P. 199-205. (DOI: 10.1255/ejms.1252)
Shikov A.N., Pozharitskaya O.N., Makarova M.N., Makarov V.G., Wagner H. Bergenia crassifolia (L.) Fritsch – Pharmacology and phytochemistry.// Phytomedicine.- 2014.- Vol. 21(12).- P. 1534-1542 (DOI: 1016/j.phymed.2014.06.009)
Salminen J.-P., Shikov A.N., Karonen M., Pozharitskaya O.N., Kim J., Makarov V.G., Hiltunen R. Galambosi B. Rapid profiling of phenolic compounds of green and fermented Bergenia crassifolia leaves by UPLC-DAD-QqQMS and HPLC-DAD-ESI-QTOF-MS. // Natural Product Research.- 2014.- Vol. 28(19).- P.1530-1533. (DOI: 10.1080/14786419.2014.923999)
Shikov A.N., Pozharitskaya O.N., Makarova M.N., Makarov V.G., Yang W-Z., Guo D-A. Oplopanax elatus (Nakai) Nakai: chemistry, traditional use and pharmacology// Chinese Journal of Natural Medicines.- 2014.- Vol. 12(10).- P. 721-729. (DOI: 3724/SP.J.1009.2014.00721)
Косман В.М., Крышень К.Л., Крышень А.А., Гаврилин М.В., Пожарицкая О.Н., Макарова М.Н. Валидация теста «Аномальная токсичность» для стандартизации субстанции инсулина // Разработка и регистрация лекарственных средств. -2016, № 3. –С. 78-84.