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      Development of a Simple RP-HPLC-UV Method for Determination of Azithromycin in Bulk and Pharmaceutical Dosage forms as an Alternative to the USP Method

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          Abstract

          The present study was designed to develop a simple, validated liquid chromatographic method for the analysis of azithromycin in bulk and pharmaceutical dosage forms using ultraviolet detector. The best stationary phase was determined as C18 column, 5 μm, 250 mm × 4.6 mm. Mobile phase was optimized to obtain a fast and selective separation of the drug. Flow rate was 1.5 mL/min, Wavelength was set at 210 nm and the volume of each injection was 500 μL. An isocratic methanol/buffer mobile phase at the ratio of 90:10 v/v gave the best separation and resolution. The proposed method was accurate, precise, sensitive, and linear over a wide range of concentration of azithromycin. The developed method has the advantage of using UV detector compared to the USP method in which electrochemical detector has been used. The validated method was successfully applied to the determination of azithromycin in bulk and pharmaceutical dosage forms.

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          Validation of high-performance liquid chromatography methods for pharmaceutical analysis. Understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization.

          G. A. Shabir (2003)
          One of the most critical factors in developing pharmaceutical drug substances and drug products today is ensuring that the HPLC analytical test methods that are used to analyze the products generate meaningful data. The US Food and Drug Administration (FDA) and United States Pharmacopeia (USP) have each recognized the importance of this to the drug development process and have separately increased validation requirements in recent years. A third source, the International Conference on Harmonization (ICH), has added requirements that, when combined with the previous two sources, have led to three different sets of validation requirements leaving the industry in a state of confusion. This paper is written to clear up the confusion over the validation requirements that are presented by each of these three sources.
          Article 0 comments Cited 72 times – based on 0 reviews     Review now
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            Quantitative determination of the macrolide antibiotics erythromycin, roxithromycin, azithromycin and clarithromycin in human serum by high-performance liquid chromatography using pre-column derivatization with 9-fluorenylmethyloxycarbonyl chloride and fluorescence detection.

            J Toraño, H.-J. Guchelaar (1998)
            A validated, highly sensitive and precise high-performance liquid chromatographic (HPLC) method for the determination of the macrolides erythromycin, azithromycin, clarithromycin and roxithromycin in human serum is described. A diethyl ether extract, obtained from serum using a saturated sodium carbonate solution, was treated with 9-fluorenylmethyl-oxycarbonyl chloride (FMOC-Cl) for 40 min at 40 degrees C and chromatographed on a base-deactivated octadecyl column, maintained at 50 degrees C during elution, using an eluent composed of acetonitrile-hydrogenphosphate buffer, pH 7.5, with 0.125% triethylamine (3:2, v/v). Fluorescence detection was used at an excitation wavelength of 255 nm and an emission wavelength of 315 nm. Erythromycin, clarithromycin, roxithromycin and azithromycin were found to have retention times of 8.8, 15.7, 17.1 and 20.7 min, respectively. Recoveries ranging from 93 to 104% were found with reproducibility coefficients of variation of 1.1-5%. Mean correlation coefficients of 0.9997, 0.9998, 0.9996 and 0.9994 were found for the linear calibration curves (n = 2) of erythromycin (0.320-16.1 mg/l), roxithromycin (3.24-19.4 mg/l), clarithromycin (0.190-19.4 mg/l) and azithromycin (0.0988-4.94 mg/l), respectively.
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              Analysis of macrolide antibiotics in river water by solid-phase extraction and liquid chromatography-mass spectrometry.

              Jose Granados, Ramon Compañó, R Codony … (2006)
              A liquid chromatography-mass spectrometry (LC-MS) method was developed for the determination of five macrolides in natural water samples, using kitasamycin as surrogate. The macrolides were extracted from water samples using Oasis HLB cartridges. Pre-concentration factors up to 250 were obtained. Separation was carried out in an end-capped silica-based C18 column and mobile phases consisting of water/acetonitrile mixtures containing ammonium acetate. Detection was performed by mass spectrometry with a single quadrupole and a triple quadrupole using an electrospray interface. The quality parameters obtained with these two approaches were compared. The detection limits of the whole process were about 1 ng l(-1). The recoveries from 250 ml of water samples spiked at 25-125 ng l(-1) level were in the range 85-115%, except for azithromycin levels, which were around 70%. Erythromycin-H2O, clarithromycin and azithromyzin were found, at the sub ng l(-1) level, in the studied rivers.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Iran J Pharm Res
                Journal ID (iso-abbrev): Iran J Pharm Res
                Journal ID (publisher-id): IJPR
                Title: Iranian Journal of Pharmaceutical Research : IJPR
                Publisher: Shaheed Beheshti University of Medical Sciences (Tehran, Iran )
                ISSN (Print): 1735-0328
                ISSN (Electronic): 1726-6890
                Publication date (Print): Winter 2013
                Volume: 12
                Issue: Suppl
                Pages: 57-63
                Affiliations
                [a ] Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
                [b ] Department of Pharmaceutical Chemistry, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
                [c ] Students Research Committee, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
                Author notes
                [* ]Corresponding author: E-mail: mortazavisar@yahoo.com
                Article
                Publisher ID: ijpr-12-57
                DOI: 10.22037/ijpr.2013.1272
                PMC ID: 3813375
                PubMed ID: 24250672
                SO-VID: ec7d991c-1e65-4573-9836-8e26c14c46d3
                Copyright © © 2013 by School of Pharmacy, Shaheed Beheshti University of Medical Sciences and Health Services
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License, ( http://creativecommons.org/licenses/by/3.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : December 2012
                Date accepted : January 2013
                Categories
                Subject: Original Article

                Keywords: azithromycin,hplc,uv detection,determination,pharmaceuticals
                Data availability:
                Keywords: azithromycin, hplc, uv detection, determination, pharmaceuticals

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