Determination of spectinomycin and related substances by HPLC coupled with evaporative light scattering detection

Czasopismo : Acta Chromatographica
Tytuł artykułu : Determination of spectinomycin and related substances by HPLC coupled with evaporative light scattering detection

Autorzy :
Gwarda, R. Ł.
Medical University of Lublin Department of Physical Chemistry, Chair of Chemistry 4a Chodźki Street 20-093 Lublin Poland, radoslaw.gwarda@umlub.pl,,
Tomczyszyn, A.
University of Warsaw Faculty of Chemistry 1 Pasteura Street 02-093 Warsaw Poland,
Misicka, A.
University of Warsaw Faculty of Chemistry 1 Pasteura Street 02-093 Warsaw Poland,
Dzido, T. H.
Medical University of Lublin Department of Physical Chemistry, Chair of Chemistry 4a Chodźki Street 20-093 Lublin Poland,
Xue, X. D.
Yunnan Normal University Department of Chemistry Kunming 650092 P.R. China,
Zhang, M.
East China Normal University Department of Chemistry Shanghai 200241 P.R. China,
Xie, S. M.
Yunnan Normal University Department of Chemistry Kunming 650092 P.R. China,
Yuan, L. M.
Yunnan Normal University Department of Chemistry Kunming 650092 P.R. China, yuan_limingpd@yahoo.com.cn,
Matta, M. K.
Jawaharlal Nehru Technological University University College of Pharmaceutical Sciences Hyderabad 500 085 India,
Pilli, N. R.
Jawaharlal Nehru Technological University University College of Pharmaceutical Sciences Hyderabad 500 085 India,
Rao, J. V. L. N. S.
Yalamarty College of Pharmaceutical Sciences Visakhapatnam 530 052 India, jvlnsrao@rediffmail.com,
Abdelhay, M. H.
University of Alexandria Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy Elmessalah, Alexandria 21521 Egypt,
Gazy, A. A.
University of Alexandria Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy Elmessalah, Alexandria 21521 Egypt,
Shaalan, R. A.
rasha_shaalan@yahoo.com,
Ashour, H. K.
University of Alexandria Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy Elmessalah, Alexandria 21521 Egypt,
Krasucka, D.
National Veterinary Research Institute — National Research Institute Department of Veterinary Pharmacy Al. Partyzantów 57 24-100 Pulawy Poland,
Kowalski, C. J.
University of Life Sciences in Lublin Department of Pharmacology, Faculty of Veterinary Medicine Akademicka 12 20-033 Lublin Poland,
Osypiuk, M.
University of Life Sciences in Lublin Department of Pharmacology, Faculty of Veterinary Medicine Akademicka 12 20-033 Lublin Poland, monika.osypiuk@up.lublin.pl,
Opielak, G.
Medical University School of Lublin Human Anatomy Department Jaczewskiego 4 20-090 Lublin Poland,
Mahgoub, H.
King Abdulaziz University Department of Pharmaceutical Chemistry, Faculty of Pharmacy Jeddah Saudi Arabia, hodamahgoub@yahoo.com,
Hanafy, A.
King Abdulaziz University Department of Pharmacology and Toxicology, Faculty of Pharmacy Jeddah Saudi Arabia,
Bamane, F. H.
King Abdulaziz University Department of Biochemistry, Faculty of Medicine Jeddah Saudi Arabia,
Radwan, A. E.
University of Alexandria Department of Biotechnology, Institute of Graduate Studies and Research Alexandria Egypt,
Wen, C.
Wenzhou Medical College Laboratory Animal Centre Wenzhou 325035 China,
Zhang, Q.
Shanghai Institute of Pharmaceutical Industry Shanghai 200437 China,
He, Y.
Wenzhou Medical College Laboratory Animal Centre Wenzhou 325035 China,
Deng, M.
Wenzhou Medical College Laboratory Animal Centre Wenzhou 325035 China,
Wang, X.
Wenzhou Medical College Laboratory Animal Centre Wenzhou 325035 China,
Ma, J.
Wenzhou Medical College Function Experiment Teaching Center Wenzhou 325035 China, jianshema@gmail.com,
Wang, Y.
National Institutes for Food and Drug control (NIFDC) Beijing 100050 P.R. China,
Wang, M. J.
National Institutes for Food and Drug control (NIFDC) Beijing 100050 P.R. China,
Li, J.
National Institutes for Food and Drug control (NIFDC) Beijing 100050 P.R. China,
Yao, S. C.
National Institutes for Food and Drug control (NIFDC) Beijing 100050 P.R. China,
Xue, J.
National Institutes for Food and Drug control (NIFDC) Beijing 100050 P.R. China,
Zou, W. B.
National Institutes for Food and Drug control (NIFDC) Beijing 100050 P.R. China,
Hu, C.
National Institutes for Food and Drug control (NIFDC) Beijing 100050 P.R. China, hucq@nicpbp.org.cn,
Abstrakty : An improved ion-pairing reversed-phase high-performance liquid chromatography method coupled with evaporative light scattering detection (HPLC-ELSD) was developed to determine spectinomycin and its related substances in commercial samples. The method was validated in accordance with International Conference on Harmonization (ICH) guidelines. The specificity of the HPLC-ELSD method was similar to that of the European Pharmacopoeia (Ph. Eur.) method, and repeatability and robustness were markedly improved relative to other reported methods due to our empirical evaluation of separation columns. Indeed, it is a more specific assay of spectinomycin than traditional microbiological techniques. The HPLC-ELSD method was used to evaluate the impurity profiles of eight compounds in seven spectinomycin batches from five different companies. Liquid chromatography coupled with electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) was employed to characterize the structures of these compounds. Though the HPLC-ELSD method was not as sensitive as the Ph. Eur. method, its limit of quantitation (LOQ) (0.16%) was lower than the disregard limit (0.3%) described by the Ph. Eur. 7.0. This suggests that the HPLC-ELSD method is appropriate for routine analysis of spectinomycin and its related substances.

Słowa kluczowe : HPLC-ELSD, spectinomycin, related substances, impurity profile,
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2015
Numer : Vol. 27, no. 1
Strony : 93 – 109
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DOI :
Cytuj : Gwarda, R. Ł. ,Tomczyszyn, A. ,Misicka, A. ,Dzido, T. H. ,Xue, X. D. ,Zhang, M. ,Xie, S. M. ,Yuan, L. M. ,Matta, M. K. ,Pilli, N. R. ,Rao, J. V. L. N. S. ,Abdelhay, M. H. ,Gazy, A. A. ,Shaalan, R. A. ,Ashour, H. K. ,Krasucka, D. ,Kowalski, C. J. ,Osypiuk, M. ,Opielak, G. ,Mahgoub, H. ,Hanafy, A. ,Bamane, F. H. ,Radwan, A. E. ,Wen, C. ,Zhang, Q. ,He, Y. ,Deng, M. ,Wang, X. ,Ma, J. ,Wang, Y. ,Wang, M. J. ,Li, J. ,Yao, S. C. ,Xue, J. ,Zou, W. B. ,Hu, C. , Determination of spectinomycin and related substances by HPLC coupled with evaporative light scattering detection. Acta Chromatographica Vol. 27, no. 1/2015
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