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Pharmaceutics 2017, 9(1), 11; doi:10.3390/pharmaceutics9010011

A Robust Liquid Chromatographic Method for Confirmation of Drug Stability of Azithromycin in Bulk Samples, Tablets and Suspensions

1
Department of Pharmaceutical Chemistry, University of Nairobi, Off Ngong Road, Nairobi, P.O. Box 19676-00202 Nairobi, Kenya
2
Chemisches und Veterinäruntersuchungsamt (CVUA) Karlsruhe, Weissenburger Straße 3, 76187 Karlsruhe, Germany
*
Author to whom correspondence should be addressed.
Academic Editor: Beverley D. Glass
Received: 4 January 2017 / Revised: 6 February 2017 / Accepted: 15 February 2017 / Published: 24 February 2017
(This article belongs to the Special Issue Drug Stability)
View Full-Text   |   Download PDF [900 KB, uploaded 24 February 2017]   |  

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. View Full-Text
Keywords: azithromycin; HPLC; robust; isocratic; drug stability; degradation products azithromycin; HPLC; robust; isocratic; drug stability; degradation products
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MDPI and ACS Style

Okaru, A.O.; Abuga, K.O.; Kamau, F.N.; Ndwigah, S.N.; Lachenmeier, D.W. A Robust Liquid Chromatographic Method for Confirmation of Drug Stability of Azithromycin in Bulk Samples, Tablets and Suspensions. Pharmaceutics 2017, 9, 11.

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