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

dc.contributor.author Batrawi, Nidal
dc.contributor.author Wahdan, Shorouq
dc.contributor.author Al-Rimawi, Fuad
dc.date.accessioned 2018-09-17T09:26:43Z
dc.date.available 2018-09-17T09:26:43Z
dc.date.issued 2017-02-15
dc.description.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. en_US
dc.description.sponsorship The authors are thankful to The Advanced Veterinary Manufacturing Company (Palestine) for supporting this research. en_US
dc.identifier.issn 2218-0532
dc.identifier.uri https://dspace.alquds.edu/handle/20.500.12213/930
dc.language.iso en_US en_US
dc.publisher MDPI en_US
dc.subject amoxicillin en_US
dc.subject enrofloxacin en_US
dc.subject injectable suspension en_US
dc.subject HPLC en_US
dc.subject method development en_US
dc.subject validation en_US
dc.title A Validated Stability-Indicating HPLC Method for Simultaneous Determination of Amoxicillin and Enrofloxacin Combination in an Injectable Suspension en_US
dc.type Article en_US
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