Determination of azithromycin in raw materials and pharmaceutical formulations by HPLC coupled with an evaporative light scattering detector
A simple high-performance liquid chromatography (HPLC) method coupled with an evaporative light scattering detector (ELSD) was developed for the determination of azithromycin in raw materials and pharmaceutical formulations (injections, capsules and tablets) without any pretreatment or derivatizatio...
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Elsevier
2014-04-01
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Series: | Asian Journal of Pharmaceutical Sciences |
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Online Access: | http://www.sciencedirect.com/science/article/pii/S1818087613000950 |
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author | Aiguo Zeng Xia Liu Siruo Zhang Yan Zheng Ping Huang Kangli Du Qiang Fu |
author_facet | Aiguo Zeng Xia Liu Siruo Zhang Yan Zheng Ping Huang Kangli Du Qiang Fu |
author_sort | Aiguo Zeng |
collection | DOAJ |
description | A simple high-performance liquid chromatography (HPLC) method coupled with an evaporative light scattering detector (ELSD) was developed for the determination of azithromycin in raw materials and pharmaceutical formulations (injections, capsules and tablets) without any pretreatment or derivatization step. Azithromycin, degradation products and formulation ingredients were separated efficiently by using the mobile phase consisted of ammonium acetate (0.05 M, pH 8.0) and acetonitrile (60:40, v/v) in an isocratic mode at 0.8 ml/min flow rate. Parameters of ELSD were 60 °C for evaporation temperature and 50 psi for pressure of carrier gas (air). A logarithmic calibration curve was obtained from 50.93 to 509.30 μg/ml (r = 0.9996) for azithromycin, with the limit of detection (LOD) of 6.75 μg/ml (S/n = 3) and the limit of quantification of 22.50 μg/ml (S/n = 10). The developed method was validated and applied with satisfactory accuracy and precision for the determination of azithromycin in raw materials and pharmaceutical formulations (recovery 99–102%, RSD <1.2%, n = 3). No significant difference (t-test) was found between the results of the developed HPLC–ELSD method and the HPLC–UV or microbiological method. |
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id | doaj.art-cee2c59e07344a79bea29a6de1bb7687 |
institution | Directory Open Access Journal |
issn | 1818-0876 |
language | English |
last_indexed | 2024-04-12T00:52:59Z |
publishDate | 2014-04-01 |
publisher | Elsevier |
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series | Asian Journal of Pharmaceutical Sciences |
spelling | doaj.art-cee2c59e07344a79bea29a6de1bb76872022-12-22T03:54:42ZengElsevierAsian Journal of Pharmaceutical Sciences1818-08762014-04-019210711610.1016/j.ajps.2013.12.007Determination of azithromycin in raw materials and pharmaceutical formulations by HPLC coupled with an evaporative light scattering detectorAiguo Zeng0Xia Liu1Siruo Zhang2Yan Zheng3Ping Huang4Kangli Du5Qiang Fu6School of Pharmacy, Xi'an Jiaotong University, Xi'an 710061, ChinaSchool of Pharmacy, Xi'an Jiaotong University, Xi'an 710061, ChinaDepartment of microbiology, Dalian Medical University, Dalian 116044, ChinaXi'an Institute of Food and Drug Control, Xi'an 710054, ChinaXi'an Institute of Food and Drug Control, Xi'an 710054, ChinaSchool of Pharmacy, Xi'an Jiaotong University, Xi'an 710061, ChinaSchool of Pharmacy, Xi'an Jiaotong University, Xi'an 710061, ChinaA simple high-performance liquid chromatography (HPLC) method coupled with an evaporative light scattering detector (ELSD) was developed for the determination of azithromycin in raw materials and pharmaceutical formulations (injections, capsules and tablets) without any pretreatment or derivatization step. Azithromycin, degradation products and formulation ingredients were separated efficiently by using the mobile phase consisted of ammonium acetate (0.05 M, pH 8.0) and acetonitrile (60:40, v/v) in an isocratic mode at 0.8 ml/min flow rate. Parameters of ELSD were 60 °C for evaporation temperature and 50 psi for pressure of carrier gas (air). A logarithmic calibration curve was obtained from 50.93 to 509.30 μg/ml (r = 0.9996) for azithromycin, with the limit of detection (LOD) of 6.75 μg/ml (S/n = 3) and the limit of quantification of 22.50 μg/ml (S/n = 10). The developed method was validated and applied with satisfactory accuracy and precision for the determination of azithromycin in raw materials and pharmaceutical formulations (recovery 99–102%, RSD <1.2%, n = 3). No significant difference (t-test) was found between the results of the developed HPLC–ELSD method and the HPLC–UV or microbiological method.http://www.sciencedirect.com/science/article/pii/S1818087613000950AzithromycinHigh-performance liquid chromatographyEvaporative light scattering detectorDetermination |
spellingShingle | Aiguo Zeng Xia Liu Siruo Zhang Yan Zheng Ping Huang Kangli Du Qiang Fu Determination of azithromycin in raw materials and pharmaceutical formulations by HPLC coupled with an evaporative light scattering detector Asian Journal of Pharmaceutical Sciences Azithromycin High-performance liquid chromatography Evaporative light scattering detector Determination |
title | Determination of azithromycin in raw materials and pharmaceutical formulations by HPLC coupled with an evaporative light scattering detector |
title_full | Determination of azithromycin in raw materials and pharmaceutical formulations by HPLC coupled with an evaporative light scattering detector |
title_fullStr | Determination of azithromycin in raw materials and pharmaceutical formulations by HPLC coupled with an evaporative light scattering detector |
title_full_unstemmed | Determination of azithromycin in raw materials and pharmaceutical formulations by HPLC coupled with an evaporative light scattering detector |
title_short | Determination of azithromycin in raw materials and pharmaceutical formulations by HPLC coupled with an evaporative light scattering detector |
title_sort | determination of azithromycin in raw materials and pharmaceutical formulations by hplc coupled with an evaporative light scattering detector |
topic | Azithromycin High-performance liquid chromatography Evaporative light scattering detector Determination |
url | http://www.sciencedirect.com/science/article/pii/S1818087613000950 |
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