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Sci. Pharm. 2015, 83(2), 297-309; doi:10.3797/scipharm.1411-04

Forced Degradation Behaviour of Fluphenazine Hydrochloride by LC and Characterization of its Oxidative Degradation Product by LC–MS/MS

Department of Pharmaceutical Sciences, Saurashtra University, Rajkot – 360005, Gujarat, India.
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Received: 10 November 2014 / Accepted: 22 December 2014 / Published: 22 December 2014
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Abstract

A novel, stability-indicating high-performance liquid chromatographic (HPLC) method is delivered for the determination of fluphenazine hydrochloride (FPZ) and its degradation products. The forced degradation testing of FPZ was carried out for hydrolytic, oxidative, photolytic, and thermal degradation. The degrada-tion appeared using a reversed-phase C18 column at ambient temperature with a mobile phase comprised of methanol : acetonitrile : (10 mM) ammonium acetate (70:15:15,v/v/v) pH 6.0, adjusted with acetic acid, having a flow rate of 1 ml min−1 and a detection wavelength at 259 nm. Primarily, the maximum degradation products were formed under oxidative stress conditions. The product was distinguished through LC-MS/MS fragmentation studies. Based on the results, a more complete degradation pathway for the drug could be proposed. The modernized method was found to be precise, accurate, specific, and selective. The method was found to be suitable for the quality control of fluphenazine hydrochloride in the tablet as well as in stability-indicating studies.
Keywords: Fluphenazine hydrochloride; Force degradation study; HPLC; Stability indicating assay; LC-MS/MS Fluphenazine hydrochloride; Force degradation study; HPLC; Stability indicating assay; LC-MS/MS
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

THUMMAR, K.N.; GHAVA, D.J.; MISTRY, A.; VACHHANI,, A.; SHETH, N.R. Forced Degradation Behaviour of Fluphenazine Hydrochloride by LC and Characterization of its Oxidative Degradation Product by LC–MS/MS. Sci. Pharm. 2015, 83, 297-309.

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