Abstract
A simple, isocratic and robust RP-HPLC method for the analysis of azithromycin was developed, validated and applied for the analysis of bulk samples, tablets and suspensions. The optimum chromatographic conditions for separation were established as a mobile phase comprised of acetonitrile-0.1 M KH2PO4 pH 6.5–0.1 M tetrabutyl ammonium hydroxide pH 6.5-water (25:15:1:59 v/v/v/v) delivered at a flow rate of 1.0 mL/min. The stationary phase consisted of reverse-phase XTerra® (250 mm × 4.6 mm i.d., 5 µm particle size) maintained at a temperature of 43 °C with a UV detection at 215 nm. The method was found to be linear in the range 50%–150% (r2 = 0.997). The limits of detection and quantification were found to be 0.02% (20 µg) and 0.078% (78 µg), respectively, with a 100.7% recovery of azithromycin. Degradation products of azithromycin in acidic and oxidative environments at 37 °C were resolved from the active pharmaceutical ingredient and thus the method is fit for the purpose of drug stability confirmation.
Highlights
Azithromycin is a semi-synthetic macrolide antibiotic used clinically for a wide range of bacterial infections [1,2]
The analytical method ought to be selective for AZT in the presence of related substances, namely the synthetic intermediates azathromycin (AZA), erythromycin A oxime (EAOX) and erythromycin A imino ether (EAIE) and the degradation products
This paper describes validation and and application application of of aa selective, isocratic and and robust describes the the development, development, validation selective, isocratic robust liquid liquid chromatographic method for the analysis of azithromycin in bulk samples and oral dosage forms
Summary
Azithromycin is a semi-synthetic macrolide antibiotic used clinically for a wide range of bacterial infections [1,2]. Liquid chromatography is the method of choice for the analysis of azithromycin in bulk samples and formulations since it is able to determine azithromycin in the presence of related substances. The current liquid chromatographic methods for the analysis of azithromycin utilize relatively expensive columns, unstable detectors and high pH. The sample matrix while polymerare columns are more relatively more expensive to silica-based This calls for use of pHand temperature-stable strategies to improve on column longevity, stability columns. This calls for use of pH- and temperature-stable strategies to improve on column longevity, and peakand parameters Such a method be usedcan forbe theused routine control of azithromycin stability peak parameters. Such acan method for quality the routine quality control of bulk samples and formulations as well as the market surveillance of samples.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
