A Validated Stability-Indicating HPLC Method for Simultaneous Determination of Amoxicillin and Enrofloxacin Combination in an Injectable Suspension
Date
2017-02-15
Authors
Batrawi, Nidal
Wahdan, Shorouq
Al-Rimawi, Fuad
Journal Title
Journal ISSN
Volume Title
Publisher
MDPI
Abstract
The combination of amoxicillin and enrofloxacin is a well-known mixture of veterinary
drugs; it is used for the treatment of Gram-positive and Gram-negative bacteria. In the scientific
literature, there is no high-performance liquid chromatography (HPLC)-UV method for the
simultaneous determination of this combination. The objective of this work is to develop and
validate an HPLC method for the determination of this combination. In this regard, a new, simple and
efficient reversed-phase HPLC method for simultaneous qualitative and quantitative determination
of amoxicillin and enrofloxacin, in an injectable preparation with a mixture of inactive excipients, has
been developed and validated. The HPLC separation method was performed using a reversed-phase
(RP)-C18e (250 mm 4.0 mm, 5 m) column at room temperature, with a gradient mobile phase
of acetonitrile and phosphate buffer containing methanol at pH 5.0, a flow rate of 0.8 mL/min and
ultraviolet detection at 267 nm. This method was validated in accordance with the Food and Drug
Administration (FDA) and the International Conference on Harmonisation (ICH) guidelines and
showed excellent linearity, accuracy, precision, specificity, robustness, ruggedness, and system
suitability results within the acceptance criteria. A stability-indicating study was also carried
out and indicated that this method can also be used for purity and degradation evaluation of
these formulations.
Description
Keywords
amoxicillin , enrofloxacin , injectable suspension , HPLC , method development , validation