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Chromatography method transfers from HPLC to a new generation instrument UPLC and studies on force degradation behavior of deflazacort | Abstract
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Abstract

Chromatography method transfers from HPLC to a new generation instrument UPLC and studies on force degradation behavior of deflazacort

Author(s): Madhavi Patel, Hetal Jebaliya, Batuk Dabhi, Yashwantsinh Jadeja, Nidhi Jani, Deepali Desai, Nirag Mavani, Bhawani Singh Yadav and Anamik Shah

Study describes the development of an efficient, cost-effective, rapid and sensitive method of analysis of deflazacort, with a new generation equipment ultra performance liquid chromatography with photo diode array detector as per international conference on harmonization guidelines. The analytical method validation was compared with high performance liquid chromatography with ultra violate detector. Chromatography was carried out on an UPLC BEH@C18 column (50×2.1 mm, particle size 1.7 μm) whereas for high performance liquid chromatography with ultra violate detector; analysis done on Sunfire C18 column (150x4.6 mm, particle size 5 μm) was used. The mobile phase for ultra performance liquid chromatography consisted of methanol: water (70: 30 v/v) with a flow rate of 0.25 mL/min, whereas for high performance liquid chromatography it was 80: 20 v/v and flow rate 1.0 mL/min respectively was taken. The detection was achieved at 240 nm for both instruments. The stability indicating method was confirmed by various stress studies like acidic, alkaline, oxidative, photolytic and thermal as per international conference on harmonization recommendations. The analytical method validation was performed on ultra performance liquid chromatography and all parameters e.g. solution stability, system suitability, accuracy, precision, linearity and range, robustness, limit of detection and limit of quantification and forced degradation study met the acceptance criteria as per international conference on harmonization guidelines. The degradation products were well separated in ultra performance liquid chromatography. Additionally, the major degradation product of deflazacort was identified by liquid chromatography-electron spray ionization coupled with mass detector.