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Sci. Pharm. 2013, 81(2), 493-504; doi:10.3797/scipharm.1301-15

Determination of Cefixime by a Validated Stability-Indicating HPLC Method and Identification of its Related Substances by LC-MS/MS Studies

1
Department of Chemistry, Faculty of Science, Alzahra University, Vanak, Tehran, Iran
2
Medicinal Plants & Drugs Research Institute, Shahid Beheshti University, G. C., Evin, Tehran, Iran
3
Jaber Pharmaceutical Companies, Tehran, Iran
4
Instrumental Analytical Chemistry Laboratory. Daana Pharma. Co. Factory: 15th Km, Tabriz-Tehran Rd, Tabriz, Iran
5
Department of Pharmaceutical and Medicinal Chemistry, National Research Centre, Dokki 12311 Cairo, Egypt
*
Authors to whom correspondence should be addressed.
Received: 19 January 2013 / Accepted: 18 February 2013 / Published: 18 February 2013
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Abstract

Cefixime is an important cephalosporin antibiotic that easily decomposes and releases different related substances in preparation and storage steps. The objective of the current study was to develop a simple, precise, and accurate isocratic liquid chromatography (LC) method for the determination of cefixime in the presence of its related substances generated from thermal stress in the bulk drug. The chromatographic conditions were comprised of a reversed‐phase C18 column (4.6 × 250 mm, 5 μm) with a mobile phase composed of water: acetonitrile (85:15 v/v, with 0.5% formic acid) and ultraviolet detection (UV). Some thermal degradation products were identified using a proposed liquid chromatography-mass spectrometry method. Five peaks (A, B, C, D, and E impurities based on British Pharmacopoeia) were known and a few unknown peaks appeared in the thermal stress solution of cefixime. The linear regression analysis data for the calibration plot of the LC-UV method showed a good linear relationship in the concentration range 0.9–1000.0 μg mL−1. The recovery of the optimized method was between 94.6 and 98.4% and the inter- and intra-day relative standard deviations were less than 3.3%. The obtained results shown in the LC-UV proposed method can be conveniently used in a quality control laboratory for routine analysis of cefixime for the assay and related substances, as well as for the evaluation of stability samples of bulk drugs.
Keywords: Cefixime; Related substances; LC-MS/MS; Bulk drug; Impurities Cefixime; Related substances; LC-MS/MS; Bulk drug; Impurities
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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MDPI and ACS Style

TALEBPOUR, Z.; POURABDOLLAHI, H.; RAFATI, H.; ABDOLLAHPOUR, A.; BASHOUR, Y.; ABOUL-ENEIN, H.Y. Determination of Cefixime by a Validated Stability-Indicating HPLC Method and Identification of its Related Substances by LC-MS/MS Studies. Sci. Pharm. 2013, 81, 493-504.

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