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Sci. Pharm. 2017, 85(1), 6; doi:10.3390/scipharm85010006

A Validated Stability-Indicating HPLC Method for Simultaneous Determination of Amoxicillin and Enrofloxacin Combination in an Injectable Suspension

1
The Advanced Veterinary Company, Ramallah,99765, Palestine
2
Department of Chemistry and Chemical Technology, Faculty of Science and Technology, Al-Quds University, Jerusalem 20002, Palestine
*
Author to whom correspondence should be addressed.
Academic Editor: Gernot Eller
Received: 12 November 2016 / Revised: 2 February 2017 / Accepted: 2 February 2017 / Published: 16 February 2017
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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 μm) 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. View Full-Text
Keywords: amoxicillin; enrofloxacin; injectable suspension; HPLC; method development; validation amoxicillin; enrofloxacin; injectable suspension; HPLC; method development; validation
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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. (CC BY 4.0).

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Batrawi, N.; Wahdan, S.; Al-Rimawi, F. A Validated Stability-Indicating HPLC Method for Simultaneous Determination of Amoxicillin and Enrofloxacin Combination in an Injectable Suspension. Sci. Pharm. 2017, 85, 6.

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