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Novel Gas Chromatographic Method Development And Validation Of Orphenadrine Citrate
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| Author:
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MOUNIKA.P, VIJAYA VEMANI, V.V.NISHANTH.G, POULAMI DAS, ANANDKUMAR TENGLI, CHANDAN R.S
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| Abstract:
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Orphenadrine Citrate was developed with a simple and novel Gas Chromatographic (GC) method. The gas chromatography was designed with a detector of flame ionization (GC-FID).Orphenadrine Citrate was an analogue of diphenhydramine, which exhibits antihistaminic and anticholinergic activities. T The chromatographic determination was achieved on a ZB-Drug-1 column (30.0mX0.25mm). The nitrogen was used as carrier gas. Methanol was used as a diluent. At a pressure of 130.8kPa, with a flow rate of 14.0mL/min, the prominent peak for Orphenadrine Citrate was obtained at 5.08min. Differential scanning calorimetry (DSC) have been used to measure the melting point of Orphenadrine Citrate and 138-151oC were observed. The initial oven temperature was set at 50 °C for 10 min and programmed at 10 °C min-1 at a final temperature of 200 °C for 10 min. The detector temperature was maintained at 280°C respectively. According to ICH guidelines, the established method was validated and found to be specific. The linearity range was between 100-500 µg/Ml respectively. Orphenadrine citrate was subjected to forced degradation studies, and was found that under acidic, basic and peroxide condition the drug had been degraded (2.5%, 3.1%, 4.2%) respectively.
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| Keyword:
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Differential scanning calorimetry, Flame ionization detector, Forced degradation, Gas Chromatography, Orphenadrine Citrate, ZB-Drug-1 column.
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.03.008
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| Download:
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