Research Article | Volume: 7, Issue: 9, September, 2017

Development and validation of a stability-indicating RP-HPLC method for the detection and quantification of azithromycin in bulk, and self-emulsifying drug delivery system (SEDDs) formulation

Reem Abou Assi Yusrida Darwis Ibrahim M. Abdulbaqi Shaik Mohammed Asif   

Open Access   

Published:  Sep 30, 2017

DOI: 10.7324/JAPS.2017.70903
Abstract

The objective of this work is to develop and validate a simple, rapid and specific reverse phase HPLC–UV method for the determination of azithromycin (AZM) in bulk, and self-emulsifying drug delivery system (SEDDs). The separation was done using Hypersil GOLD C-18 analytical column packed with deactivated silica (250 mm x 4.6 mm ID x 5 µm) kept at 60 °C, ammonium acetate solution (30 mmolL−1, pH= 6.8) and acetonitrile (18:82, v/v) as the mobile phase, and UV detection at 210 nm. Samples were eluted isocratically at a flow rate of 0.7 mL min−1.Forced degradation studies on AZM in bulk and the developed formulation were carried out. The method was validated for system suitability, specificity, linearity, precision, and accuracy. Theoretical plates (N > 1500), tailing factor (T ≤ 1.5), and resolution (Rs > 3) were as per United States Pharmacopeia (USP). There were no interferences by SEDDs excipients and AZM degradation products. The linearity was observed over the concentration range of 5–200 μg mL-1 (R2 > 0.9999).The limit of detection (LOD) and limit of quantification (LOQ) were 0.476 µg mL-1 and 1.443 µgmL-1 respectively. the developed method was statistically confirmed to be accurate, precise, and reproducible.


Keyword:     Azithromycin Self-emulsifying Drug Delivery System SEDDsStress degradation Stability-indicating HPLC–UV.


Citation:

Assi RA, Darwis Y, Abdulbaqi IM, Asif SM. Development and validation of a stability-indicating RP-HPLC method for the detection and quantification of azithromycin in bulk, and selfemulsifying drug delivery system (SEDDs) formulation. J App Pharm Sci, 2017; 7 (09): 020-029.

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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