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建立一种毛细管电泳法,用于在对乙酰氨基酚存在的情况下测定片剂中的柠檬酸奥芬那君。

Development of a capillary electrophoresis method for the determination of orphenadrine citrate in tablets in the presence of paracetamol.

机构信息

Department of Pharmaceutical Sciences, Faculty of Pharmacy, University of Jordan, Queen Rania Street, Amman, Jordan.

出版信息

Saudi Pharm J. 2010 Oct;18(4):233-7. doi: 10.1016/j.jsps.2010.07.007. Epub 2010 Aug 2.

Abstract

A validated method using capillary electrophoresis was developed, for the determination of orphenadrine citrate in its tablet formulations, in the presence of paracetamol. The method employs a running buffer of 30 mM pentane sulfonate sodium, dissolved in 20 mM MOPS buffer pH 7.7. Samples were injected using hydrodynamic sample injection mode (25 mbar, for 25 s), using positive polarity of 25 kV, at a constant temperature of 30 °C. Samples of orphenadrine citrate alone or in mixture solutions with paracetamol were exposed to various degradation conditions, and were electrophoresed using the recommended condition. The method was found to be specific, linear (r (2) = 0.994), precise, accurate, and robust, with an LOQ of 0.02 mg/mL. The proposed method was successfully applied for measurement of the percentage per label of orphenadrine citrate in commercially available tablets.

摘要

建立了一种使用毛细管电泳法的验证方法,用于在对乙酰氨基酚存在下测定其片剂制剂中的柠檬酸奥芬那君。该方法采用 30mM 戊烷磺酸钠的运行缓冲液,溶解在 20mM MOPS 缓冲液 pH 7.7 中。使用 25kV 的正极性,在 30°C 的恒定温度下,以 25mbar 的压力进行 25s 的水力样品进样模式进样。单独的柠檬酸奥芬那君样品或与对乙酰氨基酚的混合溶液样品在各种降解条件下进行电泳,并使用推荐的条件进行电泳。该方法被证明具有特异性、线性(r (2) = 0.994)、精确、准确和稳健,LOQ 为 0.02mg/mL。该方法成功应用于测量市售片剂中柠檬酸奥芬那君的标签百分比。

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