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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Main Authors: Aiguo Zeng, Xia Liu, Siruo Zhang, Yan Zheng, Ping Huang, Kangli Du, Qiang Fu
Format: Article
Language:English
Published: Elsevier 2014-04-01
Series:Asian Journal of Pharmaceutical Sciences
Subjects:
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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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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